FDA/USDA ~ May ~ Alerts & Safety ~ 2020


  • Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.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 is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label.

    .

    Product Strength Pack Size NDC Number
    Metformin Hydrochloride Extended-Release Tablets, USP 500mg 100’s Bottle 60505-0260-1

    The affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains. Apotex Corp. is in a process of notifying its affected direct account Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

    Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (option 1) (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

    Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.comConsumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

  • Ramar Foods of Pittsburg, CA, is recalling its 14 ounce packages of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product out of an abundance of caution because of the potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.The ice cream product being recalled was available for purchase at select Target stores in FL, GA, SC, and NC. Only thirty-three (33) containers of the ice cream product were purchased by consumers and the remaining containers have been removed from commerce. The ice cream affected comes in a 14 ounce, printed paper container with UPC# 8685400001, and a Best Before date of 10/08/2021 printed on the bottom.No illnesses have been reported to date in connection with this product.The potential for contamination was discovered after internal routine testing by Ramar Foods revealed the presence of Listeria monocytogenes in some packages of the ice cream.

    Production of the recalled product has been voluntarily suspended while we continue to work with FDA to investigate and take appropriate corrective measures.

    Consumers who purchased the Peekaboo branded Mint Chocolate Chip with Hidden Spinach with the

    Best Buy date of 10/08/2021 should not consume the product and will be offered a full refund.

    Consumers with questions, or who would like to request an immediate refund, may contact Ramar Foods. Consumer contact: 844-491-7869, M-F 8-5pm EST; ramarfoods5691@stericycle.com.

  • New Hoque and Sons, Inc. of Maspeth, NY is recalling Radhuni Curry Powder, contained in 400g plastic bottles, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.Radhuni Curry Powder was distributed in New York City, New York, including grocery stores in Jamaica, Jackson Heights, and the Bronx. The product was distributed to grocery stores between 4/17/2020 and 4/21/2020. They were then physically removed from the stores on 5/14/2020.The product is labeled “Radhuni Curry Powder”. The product is contained in 400g clear, plastic bottles, with an expiration date of 01/02/2022, which can be found printed on the side of the container.No illnesses have been reported to date.The recall was as the result of a routine sampling program by the FDA, which revealed that the finished products contained the bacteria. The company has ceased the distribution of the contaminated products and has also physically removed the contaminated products from stores as FDA and New Hoque and Sons, Inc. continue their investigation as to what caused the problem.Consumers who have purchased Radhuni Curry Powder are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 718.391.0992 from Monday – Friday between the hours of 9am and 5pm EST.
  • Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to be related to this recall.NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images.To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts.

    Product

    NDC

    Lot #

    Exp. Date

    NP Thyroid 30 mg 42192-329-01 M329A19-1 20-Dec
    M329H18-1 20-Jul
    M329J18-1 20-Aug
    M329J18-2 20-Aug
    M329J18-3 20-Aug
    M329M18-2 20-Nov
    NP Thyroid 60 mg 42192-330-01 M330J18-2A 20-Aug
    M330J18-3 20-Aug
    NP Thyroid 90 mg 42192-331-01 M331G18-1 20-Jun
    M331J18-1 20-Aug
    M331J18-2 20-Aug
    M331M18-1 20-Nov
    M331M18-2 20-Nov

    Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

    Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. 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.

  • Conagra Brands, Inc., Russellville, Ark. and Marshall, Mo. establishments, are recalling approximately 276,872 pounds of not ready-to-eat chicken and turkey bowl products because the products may contain extraneous material, specifically small rocks, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

    The scope of this recall has been expanded to include Healthy Choice Power Bowls Chicken Feta & Farro Bowls, Healthy Choice Power Bowls Unwrapped Burrito Scramble Power Bowls, and Healthy Choice Power Bowls Turkey Sausage & Egg Scramble Power Bowls produced on various dates. The products were produced at two different establishments.

    The following additional products are subject to recall: [View Labels (PDF Only)]

    • 9.5-oz cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro” with lot code 5006006620 and best by date of DEC 01 2020. The product bears establishment number “P-115” on the side panel adjacent to the lot code.
    • 7.2-oz cartons containing “Heathy Choice POWER BOWLS Unwrapped Burrito Scramble” with UPC 7265500082, lot code 5009002920 and best if used by date of OCT 25 2020. The product bears establishment number “P9” on the side panel adjacent to the lot code.
    • 7.2-oz cartons containing “Healthy Choice POWER BOWLS Turkey Sausage & Egg White Scramble” with UPC 7265500081, lot code of 5009003020 and a best if used by date of OCT 26 2020 on the label. The product bears establishment number “P9” on the side panel adjacent to the lot code.
    • 204-gram cartons containing “Healthy Choice POWER BOWLS BOILS ÈNERGIE PETIT DÈJJEUNER TOUTE JOURNÈE Turkey Sausage & Egg White Scramble” with UPC 7265500202, lot code of 5009003020 and a best if used by date of OCT 26 2020 on the label. The product bears establishment number “EST P9” on the side panel adjacent to the lot code.
    • 204-gram cartons containing “Heathy Choice POWER BOWLS BOILS ÈNERGIE PETIT DÈJJEUNER TOUTE JOURNÈE Unwrapped Burrito Scramble” with UPC 7265500203, lot code 5009002920 and best if used by date of OCT 25 2020. The product bears establishment number “EST P9” on the side panel adjacent to the lot code.

    On April 10, 2020. Conagra Brands, Inc., recalled approximately 130,763 pounds of not ready-to-eat chicken bowl products produced on Jan. 23, 2020. The products bear establishment number “EST P115” inside the USDA Mark of inspection.

    • 9.5-oz. cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro” with lot code 5006002320, UPC code 072655001800 and a best by date of 10/19/2020 on the label.
    • 9.5-oz. cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro, BOILS ÈNERGIE Poulet feta et épeautre” with lot code 5006002320, UPC code 072655003026 and a best by date of 10/19/2020 on the label.

    These items were shipped to retail locations nationwide and exported to Canada.

    The problem was discovered when the firm received additional consumer complaints about rocks being in the products and the firm then notified FSIS of the issue.

     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. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

    Consumers with questions about the recall can contact Conagra Brands Consumer Care at 1-800-672-8240 or at Consumer.Care@conagra.com. Members of the media with questions about the recall can contact Daniel Hare, Conagra Brands Senior Director of Communication, at (312) 549-5355.

  • Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement.Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product.The product labels states that benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress. The product is packaged in 30 milliliter bottles; which could come in 9 count displays in Kraft paper packaging. The affected Kore Organic Watermelon CBD Oil lots include Batch#730 Lot#K018. The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30 milliliter bottle. The product was distributed nationwide by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Personnel, Tradeshow Samples, and by Summitt Labs.Summitt Labs is notifying its distributors and customers by email, phone, and personal visits to ensure the return of all recalled product. Consumers, distributors and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop using the product.Any consumer with Lot #K018 Batch #730 in their possession are urged to contact Summitt Labs by phone at (833) 810-5673 Monday-Friday 8a.m. to 5p.m. EST, or through the website at http://www.Koreorganic.com. Any consumer with Lot #K018 Batch #730 should return this product to the place of purchase for a full monetary refund. If that is denied, please contact Summitt Labs at the above number for refund information and any other information regarding this recall. 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. Media with any questions about this recall should contact Christopher Cardamone, Esq. at (813) 842-7266 Monday-Friday 8 a.m. to 5p.m. EST.
  •  Ideal Foods, a North Las Vegas, Nev. establishment, is recalling approximately 3,302 pounds of meat and poultry flatbread pizza products that were produced, packed and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

    The flatbread pizza products made with meat and poultry items were produced on various dates from October 2019 to April 2020. The following products are subject to recall: [View Labels (PDF Only)]

    • 13.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza CARNE ASADA”.
    • 13-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza CHICKEN SPINACH ARTICHOKE”.
    • 16.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza SIZZLIN JALAPEÑO”.
    • 14.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza MEAT LOVERS”.

    The products subject to recall bear establishment number “EST. 45351A” or “P-45351A” inside the USDA mark of inspection. These items were shipped to a distributor and retail locations in California.

    The problem was discovered during routine FSIS surveillance activities, which determined that the firm produced the products without the benefit of inspection.

    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction 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. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

    Consumers and members of the media with questions about the recall can contact John Hagen, Chief Financial Operations Officer, Ideal Foods, at (702) 647-3663.

  • ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer’s Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint.Administration of a drug product that contains metal particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events related to this recall.Lactated Ringer’s Injection, USP is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human and veterinary use.The affected product lot, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in July 2019 is listed below:

    NDC Number

    Product Description

    Lot Number

    Expiration Date

    Configuration

    Manufacture
    Date

    Distribution
    Dates

    0409-7953-09 Lactated
    Ringer’s
    Injection, USP
    07-514-FW 01-Jul-2021 1000 mL Flexible
    Container
    July 2019 September 2019
    – October 2019

    ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase.

    Customers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    • The Center for Veterinary Medicine recommends calling the drug company to report the adverse drug experience or product defect. The drug company responsible for the approved product(s) is required to submit reports of adverse drug experiences and product defects to FDA.
    • If you prefer to report directly to the FDA, you can submit FORM FDA 1932a,
    • “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report”. You can use this form to report adverse drug experiences for any animal drug (approved or not approved by FDA) or animal device. Unapproved animal drugs include compounded drug products.
    • Download the fillable 1932a electronic form and email the completed form to CVM1932a@fda.hhs.gov
    • If you have a question about ADE reporting or need a hard copy of the form, contact CVM by email at AskCVM@fda.hhs.gov, by phone at 1-888-FDA-VETS (1-888-332-8387)
  • Out of abundance of caution, and in line with its commitment to consumer satisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applicator of some units. While this is unlikely to cause serious injury there is a potential risk of temporary skin and/or eye allergy and irritation. To date, no adverse reactions or injuries have been reported.This product was manufactured in the United States and distributed nationwide.The below table provides details of the product affected by this recall. No other Becca Cosmetics products are affected by this issue.
    Product Name Batch Size Product Description UPC
    Becca Cosmetics
    Light Shifter Brightening Concealer
    0030A,
    9308A,
    0052A,
    0052C,
    9291A,
    9309A,
    0036A,
    0037A,
    0038A,
    0038B,
    0041A,
    9289A,
    0062A,
    0062B,
    0062C,
    9283A,
    9284A,
    9287A,
    9288A
    3.2 mL (only size available) Concealer wand with silver overlay, and a white secondary carton 9331137030037
    9331137030044
    9331137030051
    9331137030068
    9331137030075
    9331137030099
    9331137030082
    9331137030105

    If you have this product, please stop using it and contact the place of purchase regarding a refund.

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


    Company Contact Information

    Media:
    Justine Dunton-Rose
     jduntonr@beccacosmetics.com