• Lakeside Refrigerated Services, a Swedesboro, N.J. establishment, is recalling nearly 43,000 pounds of ground beef products, reports the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). The recall was issued due to potential E. coli O157:H7 contamination.

  The ground beef—much of it grass-fed—was sold under the Marketside Butcher and Thomas Farms brands and shipped to Walmart and other retailers nationwide. All items were produced on June 1, 2020 and include the establishment number EST. 46841 in the USDA mark of inspection. The meat has use or freeze by dates of 6/25/20, 6/27/20, or 7/01/20, depending on the specific package size and brand.

  These are the specific items subject to recall—you can find images of their packaging here.

  • 1-lb. vacuum packages containing “MARKETSIDE BUTCHER ORGANIC GRASS-FED GROUND BEEF” and a use or freeze by date of 07/01/20 and lot code P-53298-82.
  • 1-lb. vacuum packages containing four ¼ lb. pieces of “MARKETSIDE BUTCHER ORGANIC GRASS-FED GROUND BEEF PATTIES” and a use or freeze by date of June 27, 2020 and lot code P-53934-28.
  • 3-lb. vacuum packages containing three 1 lb. pieces of “MARKETSIDE BUTCHER ORGANIC GRASS-FED GROUND BEEF 93% LEAN / 7% FAT” and a use or freeze by date of 07/01/20 and lot code P53929-70.
  • 1-lb. tray packages containing four ¼ lb. pieces of “THOMAS FARMS GRASS-FED GROUND BEEF PATTIES 85% LEAN / 15% FAT” and a use or freeze by date of 06/25/20 and lot code P53944-10.
  • 4-lb. tray packages containing 10 ¼ lb. pieces of “THOMAS FARMS GRASS-FED GROUND BEEF PATTIES 80% LEAN / 20% FAT” and a use or freeze by date of 06/25/20 and lot code P53937-45.
  • 1-lb. vacuum packages containing four ¼ lb. pieces of “THOMAS FARMS GRASS-FED GROUND BEEF PATTIES 85% LEAN / 15% FAT” and a use or freeze by date of 06/27/20 and lot code P53935-25.
  • 1-lb. vacuum packages containing “VALUE PACK FRESH GROUND BEEF 76% LEAN / 24% FAT” and a use or freeze by date of 07/01/20 and lot code P53930-18.
• Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration advising consumers of potentially toxic hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, Saniderm has proactively taken necessary precautions to ensure the safety of consumers.Out of an abundance of caution, Saniderm has initiated a voluntary recall of all products produced by Eskbiochem SA de CV with a “Made in Mexico” origin.

  Risk Statement: Substantial methanol exposure “could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.”

  To date, Saniderm has not received any reports of adverse events related to the product in question.

  The product is a hand sanitizer and is packaged in 1-liter plastic bottles with an orange twist-top cap. The affected Sandiderm Advanced Hand Sanitizer include lot number 53131626, manufactured date April/1/20, clear bottle that can be further distinguished by looking at the back side label and identifying “Made in Mexico” and “Produced by: Eskbiochem SA de CV”. No other bottles distributed by Saniderm match the description above, hence all products as described above are subject to the voluntary recall. The product can be identified by the photos below. The product was distributed in Virginia, Maryland, and New Jersey on April 15,2020.

  Saniderm is notifying its distributors and customers by email and is arranging for the handling of all voluntary recalled products. All individuals that have the bottle in question should immediately stop using and contact Saniderm for guidance on the return and disposal of the product.

  Consumers with questions regarding this voluntary recall can contact Saniderm at +1 (415) 562-5502‬ or info@sanidermproducts.com from Monday-Friday 9am-6pm, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

• Fresh Express, out of an abundance of caution, has issued a voluntary recall of branded and private label salad products produced at its Streamwood, IL facility that contain iceberg lettuce, red cabbage and/or carrot ingredients due to a possible health risk from Cyclospora. According to the Centers for Disease Control and Prevention, over 200 illnesses have been reported in connection with a current outbreak of Cyclospora occurring in primarily Midwest states.Cyclosporiasis is an intestinal infection caused by the Cyclospora parasite. A person may become infected after ingesting contaminated food or water. Common symptoms include severe abdominal pain, diarrhea, nausea and vomiting, body aches and fatigue. The infection is treated with antibiotics and most people respond quickly to treatment.

  The Fresh Express recall includes only those salads that are clearly marked with the letter Z at the beginning of the Product Code, which is located in the upper right-hand corner of the front of the package. Products containing the ingredients iceberg lettuce, red cabbage and/or carrots AND displaying the Product Code Z178, or a lower number, are recalled.

  Recalled products were distributed to select retail stores between June 6 and June 26 in various states including, for example, Arkansas, Connecticut, Delaware, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Virginia, Vermont, Wisconsin, West Virginia, and the District of Columbia.

  No other Fresh Express products are subject to recall.

  Fresh Express customers have been notified of the recall and instructed to immediately remove recalled products from all store shelves, distribution, and other inventories to ensure they are no longer available for sale or consumption.

  Consumers who may have a recalled salad should discard it immediately and not eat it. Consumers with questions, or to obtain refunds, may contact the Fresh Express Consumer Response Center toll-free at (800) 242-5472 on Monday through Saturday from 8 a.m. to 7 p.m. Eastern time and on Sunday from 11 a.m. to 7 p.m. Eastern time.

• UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, UVT, INC. has not received any reports of adverse events related to this recall.

  The product is used as a hand sanitizer and is packaged in 1-liter plastic bottles. The affected SANIDERM ADVANCED HAND SANITIZER includes lot number 0530, Expiration date 04/2022. The product can be identified by the label below. Product was distributed Nationwide in the United States.

  UVT, INC. is notifying its distributors and customers by phone calls, emails and letter and is arranging for replacement and destruction of all recalled products.

  Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase. purchase.

  Consumers with questions regarding this recall can contact UVT, INC. by phone (951) 427- 3108 or e-mail to customerservice@uvt.world Monday to Friday from 9:00 am and 3:00 pm Pacific Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Salad Supplier Recall Expanded after Potential Cyclospora Contamination; Hy-Vee Pulls Additional Salads as a Result

  Hy-Vee, Inc., based in West Des Moines, Iowa, is recalling an additional 12 salads across its eight-state region due to the potential that they may be contaminated with Cyclospora. The potential for contamination was brought to Hy-Vee’s attention when Fresh Express – which manufactures the product – announced that the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control Prevention (CDC) expanded its investigation of an outbreak of Cyclospora in the upper Midwest section of the United States. The 12 salads are in addition to the 12 oz. Hy-Vee Bagged Garden Salad product that Hy-Vee pulled last week after initial notification of the investigation. Hy-Vee now has 13 private label bagged salad products (all expiration dates) that are being recalled as a result.

  The products were distributed to Hy-Vee grocery stores across its eight-state region of Iowa, Illinois, Missouri, Kansas, Nebraska, South Dakota, Minnesota and Wisconsin.

  The list below outlines the 13 products that have been recalled. No other Hy-Vee branded salads are impacted by today’s recall.

  UPC	DESCRIPTION	SIZE
  0-07450-24669	HY-VEE SOUTHWEST CHOPPED SALAD KIT	13.4 OZ
  0-07545-12053	HY-VEE SHREDDED ICEBERG	8 OZ
  0-75450-08530	HY-VEE VEGGIE DELUXE SALAD	12 OZ
  0-75450-12046	HY-VEE GREENER SUPREME BLEND	12 OZ
  0-75450-12047	HY-VEE AMERICAN BLEND SALAD	12 OZ
  0-75450-12048	HY-VEE ITALIAN BLEND SALAD	10 OZ
  0-75450-12051	HY-VEE COLESLAW MIX	16 OZ
  0-75450-12058	HY-VEE ROMAINE GARDEN SALAD	12 OZ
  0-75450-24668	HY-VEE ASIAN CHOPPED SALAD KIT	13.7 OZ
  0-75450-24670	HY-VEE SUNFLOWER CHOPPED SALAD KIT	13.2 OZ
  0-75450-24672	HY-VEE CHIPOTLE CHEDDAR CHOPPED KIT	11.4 OZ
  0-75450-24674	HY-VEE GARDEN SALAD	12 OZ
  0-75450-24715	HY-VEE AVOCADO RANCH CHOPPED KIT	12.8 OZ

  Customers who purchased any of these products should discard them or return them to their local Hy-Vee store for a full refund.

  Symptoms of cyclosporiasis begin an average of seven days after ingestion of Cyclospora. Symptoms of cyclosporiasis may include: watery diarrhea (most common), loss of appetite, weight loss, cramping, bloating, increased gas, nausea, fatigue, vomiting, and low-grade fever. If not treated, symptoms can persist for several weeks to a month or more. People who are in poor health or who have weakened immune systems may be at higher risk for severe or prolonged illness.

  Consumers with questions may contact Hy-Vee Customer Care representatives 24 hours a day, seven days a week at 1-800-772-4098.

• Pilgrim’s Pride Corporation, a Waco, Texas establishment, is recalling approximately 59,800 pounds of fully cooked chicken breast nugget products that may be contaminated with extraneous materials, specifically flexible rubber material, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

  The frozen ready-to-eat (RTE) chicken breast nugget items were produced on May 6, 2020. The following products are subject to recall [View Labels (PDF Only)] :

  • 4-lb. plastic bag packages containing “Pilgrim’s FULLY COOKED CHICKEN BREAST NUGGETS,” with a Best-By date of 06 MAY 2021 and lot code of 0127 printed on the retail package. Product cases contain lot codes 0127105009, 0127105010, 0127105011, 0127105012, 0127105013, 0127105014, 0127105015, or 0127105016 printed on the box.

  The products subject to recall bear establishment number “P-20728” printed on individual retail packages as well as product cases. These items were shipped to retail locations in Arizona, Idaho, Oregon, and Texas.

  The problem was discovered after the firm received a consumer complaint reporting rubber pieces in the chicken breast nuggets product.

  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

  FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

  FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

  Consumers with questions about the recall can contact Ed Tyrrell, Consumer Relations Manager for Pilgrim’s Pride Corporation, at (800) 321-1470. Members of the media with questions about the recall can contact Nikki Richardson, Director of Communications for Pilgrim’s Pride Corporation, at (970) 506-8028.

• Hy-Vee, Inc., said that 12 more varieties of its bagged salads are being recalled from all of its stores as part of an ongoing outbreak of cyclospora illnesses in the upper midwest United States. The Food and Drug Administration had previously only recalled the company’s garden salad products.The list of included products is now:
  • Hy-Vee Southwest Chopped Salad Kit 13.4 oz.
  • Hy-Vee Shredded Iceberg 8 oz.
  • Hy-Vee Veggie Deluxe Salad 12 oz.
  • Hy-Vee Greener Supreme Blend 12 oz.
  • Hy-Vee American Blend Salad 12 oz.
  • Hy-Vee Italian Blend Salad 10 oz.
  • Hy-Vee Coleslaw Mix 16 oz.
  • Hy-Vee Romaine Garden Salad 12 oz.
  • Hy-Vee Asian Chopped Salad Kit 13.7 oz.
  • Hy-Vee Sunflower Chopped Salad Kit 13.2 oz.
  • Hy-Vee Chipotle Cheddar Chopped Salad Kit 11.4 oz.
  • Hy-Vee Garden Salad 12 oz.
  • Hy-Vee Avocado Ranch Chopped Salad Kit 12.8 oz.

  The company said that customers should dispose of the salad immediately or return them to the store for a full refund.

  The salad mixes were sold in Iowa, Illinois, Missouri, Kansas, Nebraska, South Dakota, Minnesota, and Wisconsin.

• In cooperation with the Fresh Express recall of bagged salads potentially linked to an outbreak of Cyclospora infections in the Midwest, Jewel-Osco is voluntarily recalling bagged Signature Farms Garden Salad sold in its stores in Illinois, Indiana, and Iowa.The recalled Signature Farms Garden Salad was sold in 12-ounce bags in the Produce section. The recalled products have BEST IF USED BY dates of May 16 through July 4 (5-16-20 through 7-04-20). The BEST IF USED BY date is printed on the top right corner of the front of the package. The product has a UPC code of 21130 98135, which can be found on the back of the package and bears the unique plant number S5417.Cyclospora cayetanensis is a microscopic parasite of humans. This parasite, when it contaminates food or water and is then ingested, can cause an intestinal illness called cyclosporiasis. Most people infected with Cyclospora develop diarrhea. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted. Some people who are infected with Cyclospora do not have any symptoms. If not treated, the illness may last from a few days to a month or longer. Symptoms may seem to go away and then return one or more times.Consumers are asked to check their refrigerators for the recalled product. Consumers who have purchased the product are asked to discard or return it to the place of purchase for a refund. Customers who have questions about the recall can contact Jewel-Osco at 1-877-723-3929.
• 012-2020: Lakeside Refrigerated Services Recalls Beef Products due to Possible E.coli O157:H7 Contamination (Jun 13, 2020)
• In cooperation with Fresh Express Inc., and out of an abundance of caution, ALDI has removed Little Salad Bar Garden Salad from select stores as a precautionary measure due to possible Cyclospora infection.The recall affects all product codes of ALDI Little Salad Bar Garden Salads with use-by dates of May 16 to July 04 and distributed in the states of Arkansas, Illinois, Iowa, Indiana, Michigan, Minnesota, Missouri, North Dakota, South Dakota and Wisconsin between May 1 and June 19.If customers have the affected Little Salad Bar Garden Salad, they should discard it immediately.Customers with additional questions can contact Fresh Express Consumer Response Center toll-free at (800) 242-5472 Monday – Friday during the hours of 8 a.m. to 7 p.m. Eastern time.
• GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children’s Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children’s Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults. Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention. As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.The recall is limited to the three lots listed below:
  Children’s Robitussin® Honey Cough and Chest Congestion DM (4oz)
  NDC 0031-8760-12
  Lots: 02177 (Exp. Jan. 2022)
  02178 (Exp. Jan. 2022)

  Children’s Dimetapp® Cold and Cough (8oz)
  NDC 0031-2234-19
  Lot: CL8292 (Exp. Sep. 2021)

  These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately. Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

  Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday – Friday, 8:00am – 6:00pm EST.

• 007-2020-EXPConagra Brands, Inc. Recalls Frozen Not-Ready-To-Eat Chicken and Turkey Bowl Products due to Possible Foreign Matter Contamination(May 22, 2020)   RONG SHING TRADING NY INC. of Brooklyn, NY is recalling its 21.1oz (600g) of Xi Zhi Liang Fruit Jelly Cups (喜唧郎什果果凍杯), container code, “BEST BEFORE 12.30.2020,” because they may pose a choking hazard. Small jelly cups containing konjac powder have previously been implicated in choking deaths of children. Small konjac powder jelly cups are presently under FDA import alert 35-15 and are not permitted for entry into the United States.The recalled jelly cups were distributed nationwide in retail food stores. The product comes in pink, yellow, and blue plastic backpacks, with numerous individual plastic jelly cups inside each back pack, and a toy car in a pouch on the front of the plastic backpack. UPC code is, “6902934982138.”No incidents of consumers choking have been reported to date in connection with this product.The potential choking hazard was noted during a routine inspection by the New York State Department of Agriculture and Markets, Food Safety and Inspection.Consumers who have purchased 21.1oz (600g) packs of RONG SHING NY TRADING INC JELLY are urged to return them to the place of purchase for a full refund. Consumers who have questions may contact the company at 718-308-1177 or rongshing4757@gmail.com.
• Sold in most Waltmarts:  Lakeside Refrigerated Services, a Swedesboro, N.J. establishment, is recalling approximately 42,922 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.The raw ground beef items were produced on June 1, 2020. The following products are subject to recall: [View Labels (PDF Only)]
  • 1-lb. vacuum packages containing “MARKETSIDE BUTCHER ORGANIC GRASS-FED GROUND BEEF” and a use or freeze by date of 07/01/20 and lot code P-53298-82.
  • 1-lb. vacuum packages containing four ¼ lb. pieces of “MARKETSIDE BUTCHER ORGANIC GRASS-FED GROUND BEEF PATTIES” and a use or freeze by date of June 27, 2020 and lot code P-53934-28.
  • 3-lb. vacuum packages containing three 1 lb. pieces of “MARKETSIDE BUTCHER ORGANIC GRASS-FED GROUND BEEF 93% LEAN / 7% FAT” and a use or freeze by date of 07/01/20 and lot code P53929-70.
  • 1-lb. tray packages containing four ¼ lb. pieces of “THOMAS FARMS GRASS-FED GROUND BEEF PATTIES 85% LEAN / 15% FAT” and a use or freeze by date of 06/25/20 and lot code P53944-10.
  • 4-lb. tray packages containing 10 ¼ lb. pieces of “THOMAS FARMS GRASS-FED GROUND BEEF PATTIES 80% LEAN / 20% FAT” and a use or freeze by date of 06/25/20 and lot code P53937-45.
  • 1-lb. vacuum packages containing four ¼ lb. pieces of “THOMAS FARMS GRASS-FED GROUND BEEF PATTIES 85% LEAN / 15% FAT” and a use or freeze by date of 06/27/20 and lot code P53935-25.
  • 1-lb. vacuum packages containing “VALUE PACK FRESH GROUND BEEF 76% LEAN / 24% FAT” and a use or freeze by date of 07/01/20 and lot code P53930-18.

  The products subject to recall bear establishment number “EST. 46841” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

  The problem was discovered during routine FSIS testing. There have been no confirmed reports of adverse reactions due to consumption of these products.

  Anyone concerned about an injury or illness should contact a healthcare provider. E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

  FSIS is concerned that some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

  FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

  FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160°F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, https://www.fsis.usda.gov/safetempchart.

  Consumers and members of the media with questions about the recall can contact the Lakeside Processing Center Call Center at (856) 832-3881.

• Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:

  Product Name	NDC	Lot Number	Expiration Date
  Metformin Hydrochloride Extended-Release Tablets USP, 500mg	68180-336-07	G901203	12/2020

  The product can be identified by the NDC and the lot number available on the side of the bottle label. Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.

  Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

  Wholesalers, distributors, and retailers that have Metformin Hydrochloride Extended-Release Tablets USP, 500mg which is being recalled should discontinue distribution of the recalled product lot immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 532-1856.

  Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle.

• Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall. Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.
• FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.  If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient.Patients, pharmacists and health care professionals who have received Amneal or Impax’s epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar” by:
  1. Removing the auto-injector from the carrying case.
  2. Placing the auto-injector on a flat surface.
  3. Locating the edge of the label that states, “Peel here for further instructions.” Lift the label edge until you see the clear part of the auto-injector.
  4. Looking for the yellow “stop collar” inside the clear part of the auto-injector.
  5. If the yellow “stop collar” is not visible inside the clear part of the auto-injector, gently rotate the blue sheath remover, without pulling or removing the blue sheath remover, to observe if the yellow “stop collar” comes into view inside the clear part of the auto-injector.If yellow “stop collar” is present, then the product is safe to use, and no further action is necessary. Re-wrap the label to its original position and place the auto-injector into the carrying case.

  Epinephrine auto-injectors are not being recalled. FDA urges patients to use the epinephrine auto-injector they have on hand and be aware of the potential issues outlined in the statement above.

  Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form or submit by fax to 1-800-FDA-0178
• Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the BIOCELL® recall was announced, robust efforts were made to reach patients, however, the Company is still seeking to directly contact all U.S. BIOCELL® patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 BIOCELL® breast implant units.It is important to note the United States Food and Drug Administration (FDA) has made the following recommendation, “If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider.”¹Allergan Aesthetics will launch a multi-channel campaign which will include digital and social media advertisements further informing patients of the voluntary recall and directing them to Allergan Aesthetics’ http://www.BIOCELLinformation.com website for education on how to identify their implant type and register their implants.”Allergan Aesthetics is committed to patient safety and we are continuing to make every effort to make sure that each and every patient is made aware of the BIOCELL® recall, and knows their implant type and implant history,” said John Maltman, Vice President of Medical Affairs at Allergan Aesthetics.If patients are not aware of the BIOCELL® recall previously announced on July 24, 2019 and do not know the type of implant that they have in place or their implant history, they should either:
  • Go to www.BIOCELLinformation.com External Link Disclaimerto reach out to Allergan Aesthetics to determine if the company has their implant information.
  • Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.

  Patients who know that they have an Allergan implant, and may not have participated in device tracking previously, or who need to update their information on www.BIOCELLinformation.com. External Link DisclaimerThe website will inform them how to register for device tracking, which is strongly advised for all patients, and answer any questions they may have.

  Patients with BIOCELL® implants or tissue expanders or a history of BIOCELL® implants or tissue expanders should go to www.BIOCELLinformation.com External Link Disclaimerto learn about the BIOCELL® recall, symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the importance of breast self-examination and the need for regular breast implant monitoring.

  “We are determined to make sure every woman has the information they need related to the BIOCELL® voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority. We have partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives to raise awareness regarding the importance of breast implant tracking,” said Carrie Strom, Senior Vice President AbbVie and President Global Allergan Aesthetics.

  About the GLOBAL BIOCELL® Recall

  On July 24, 2019 Allergan initiated a voluntary global recall of its BIOCELL® breast implants and tissue expanders. Allergan has continued a global basis to ensure that patients and health care professions are notified about the BIOCELL® recall. The Company issued global press releases and distributed letters directly to healthcare professionals regarding the recall. To generate awareness and provide

  a resource for patients, the Company launched a dedicated website, http://www.BI- OCELLinformation.com, to help patients identify their breast implants and to provide information and resources related to the risk of BIA-ALCL.

  Allergan Aesthetics, an AbbVie company will continue to work closely with global regulatory authorities and societies and patient advocacy groups to provide important BIOCELL® information to patients and health care professionals regarding the voluntary recall.

  For more information on the BIOCELL® recall, please click here for the press release.

  More information on BIA-ALCL

  BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with
  BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and
  can lead to death, especially if not diagnosed early or treated promptly.

  About Allergan Aesthetics

  At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

• Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License
• Distribution Dates: February 1, 2016 to May 1, 2019
• Devices Recalled in the U.S.: 54 consignees were notified with affected product.
• Date Initiated by Firm: August 9, 2019

The StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System provides images of a patient’s brain to help surgeons navigate surgical tools and implants used during a deep brain stimulation (DBS) procedure.

Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device system. This may provide inaccurate registration data which could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures. This could result in serious or life-threatening patient harm.

As of June 2020, a total of 33 medical device reports were identified: 22 related to device malfunction and 11 related to injuries

On August 9, 2019, Medtronic sent Urgent Medical Device Correction letters to all affected customers. The letter advised physicians to weigh the benefits vs. risks of fiducial-based or fiducial-less registration methods and provided the following instructions:

Following the O-arm auto-registration step, but prior to using the StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System for intraoperative navigation:

1. Assess navigational accuracy by verifying the accuracy of the registration on several known anatomical landmarks, as described in the indications for use, before using the registration for navigation.
2. Use the StealthMerge functionality in the software, as described in the indications for use, to compare the actual location of the cannula or lead to the surgical plan.
3. Use the planning functionality in the software, as described in the indications for use, to compare the cannula to planned trajectory. This can be accomplished by making an additional plan along the axis of the cannula to evaluate cannula position.

Medtronic has also added instructions to the label on how to use the device and software. In addition, Medtronic has an updated training program to inform physicians of the inaccuracies due to undetected patient motion that resulted in this recall. FDA is continuing to work with Medtronic to determine whether additional mitigations may be needed.

Health care professionals and distributors with questions about this recall should contact Medtronic and call 1-888-826-5603 or email rs.navtechsupport@medtronic.com.

• PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin).  Monensin is an FDA-approved drug for use in certain animal feeds. However, if the feed contains excessive amounts, the feed can cause monensin toxicity in a number of animal species including goats. Goats ingesting excessive levels of monensin in feed are susceptible to injury and death. In goats, signs and symptoms can include bloated stomach, bloody urine, shortness of breath, muscle weakness or cramps, rapid breathing and death. In humans, monensin could affect handlers of highly concentrated products by causing irritation of the skin, eyes, and respiratory tract through direct exposure. People or animals who consume meat or milk from animals exposed to very high levels of monensin are at risk of indirect exposure, which could potentially lead to ingestion toxicity.Champion Meat Goat Pellets R20, Medicated Feed, was distributed to three consignees in Oregon and Washington between April 20, 2020, and April 29, 2020. NW Farm Supply in Hermiston, Oregon and in Prosser, Washington, further sold the recalled product to downstream customers.The recalled product is pelleted dry feed and bagged in poly bags with the words Payback Champion Feeds printed on the bag. Each bag weighs 50 lbs. The affected lot number 6705 HM928510 04/17/20 and the UPC code 48252 48640 are printed on the tag of each bag.Customers reported that three goats have died, and three additional goats were ill but have recovered to date.The recalled product was found to contain elevated levels of monensin due to a mixing error during manufacturing. The recalled product was put on hold pending testing after a customer complaint. Test results confirmed a higher than expected level and this recall was initiated. CHS Nutrition cannot account for up to 15 bags out of 510 bags distributed to date.If you have the Champion Meat Goat Pellets R20 Medicated fee with the affected lot number 6705 HM928510 04/17/20, please call Kent Hansen at CHS Nutrition in Hermiston, Oregon, at 800-700-2295 or 541-564-0355 between 8 a.m. to 4:30 p.m.PST for replacement. Do not feed affected product to any animal.

1. Alzheimer’s and Brain Awareness Month

2. Cataract Awareness Month

3. Hernia Awareness Month

4. Men’s Health Month

5. Myasthenia Gravis Awareness Month

6. National Aphasia Awareness Month

7. National Congenital Cytomegalovirus Awareness Month

8. National Safety Month

9. National Scleroderma Awareness Month

10. Scoliosis Awareness Month

11. National Cancer Survivors Day (June 2)

12. Men’s Health Week (June 10–16)

13. World Sickle Cell Day (June 19)

14. Helen Keller Deaf-Blind Awareness Week (June 28–July 4)