FDA/USDA ~ July~ Alerts & Safety ~ 2020


  • UPDATED 7-28-20 TO CORRECT LOT# & BATCH# – Tampa, Florida; Summitt Labs is voluntarily recalling Lot #730 Batch #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 Lot #730 Batch #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 Lot #730 Batch #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 Lot #730 Batch #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 Lot #730 Batch #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 Lot #730 Batch #K018, which is being recalled, should stop using the product.

    Any consumer with Lot #730 Batch #K018 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 #730 Batch #K018 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.

  • Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition.Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between June 3, 2019 and April 8, 2020, as well as a copy of the label:
    Product Name/Product size NDC Number Product Code Batch Number Expiration Date First Ship Date Last Ship Date
    Dexmedetomidine HCl in 0.9% Sodium
    Chloride Injection, 200 mcg / 50 mL (4 mcg / mL),
    50 mL fill in a 50 mL vial
    63323-671-50 671050 6121853 05/2021 06/03/2019 12/04/2019
    6122207 06/2021 03/12/2020 04/08/2020

    Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

    Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius- kabi.com/us/pharmaceutical-product-updatesExternal Link Disclaimer.

    Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716- 2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

  • This recall press release was issued by the firm on 06-23-2020 and is subsequently being posted by FDA at this time only to benefit the public for informational purposes.

    Human Consumption (MHR Brands)

    Tasty Drops – Berry Tincture, 1oz/300mg

    FG003175

    Tasty Drops – Berry Tincture, 1oz/500mg

    FG003137 FG003174, FG003197, FG0057

    Tasty Drops – Berry Tincture, 1oz/1500mg

    FG003141, FG003202, FG003296

    Tasty Drops – Natural Tincture, 1oz/500mg

    FG003138, FG003248

    Tasty Drops – Natural Tincture, 1oz/1500mg

    FG003142, FG003247

    Tasty Drops – Spearmint Tincture, 1oz/300mg

    FG003167

    Tasty Drops – Spearmint Tincture, 1oz/500mg

    FG003139, FG003166, FG003191, FG003225, FG003253, FG003263

    Tasty Drops – Spearmint Tincture, 1oz/1000mg

    FG003095

    Tasty Drops – Spearmint Tincture, 1oz/1500mg

    FG003143, FG003180, FG003201, FG003224, FG003262

    Tasty Drops – Vanilla Tincture, 1oz/300mg

    FG003126

    Tasty Drops – Vanilla Tincture, 1oz/500mg

    FG003140, FG003182, FG003246

    Tasty Drops – Vanilla Tincture, 1oz/1500mg

    FG003144, FG003249

    Made by Hemp – French Vanilla Tincture, 1oz/1000mg

    FG003107

    Made by Hemp – Mojito Lime Tincture, 1oz/1000mg

    FG003110

    Made by Hemp – Strawberry Crème Tincture, 1oz/1000mg

    FG003109

    Pet Consumption (MHR Brands)

    Tasty Drops – Cat Tincture 1oz/200mg

    FG003156, FG003325

    Tasty Drops – Dog Tincture 1oz/200mg

    FG003157, FG003286, FG003324

    Purfurred – Dog Tincture, 1oz/200mg

    FG003188

    Made by Hemp – Cat Tincture, 1oz/200mg

    FG003178

    Made by Hemp – Dog Tincture, 1oz/200mg

    FG003179

    Human Consumption (White Label)

    A Clean Choice – French Vanilla Tincture, 1oz/1000mg

    FG003106

    A Clean Choice – Strawberry Creme Tincture, 1oz/1000mg

    FG003108

    A Clean Choice – Spearmint Tincture, 1oz/500mg

    FG003113

    BC Hemp Co LLC – Berry Tincture, 1oz/500mg

    FG003312

    BC Hemp Co LLC – Natural Tincture, 1oz/500mg

    FG003171, FG003183, FG003316

    BC Hemp Co LLC – Spearmint Tincture, 1oz/500mg

    FG003315

    BC Hemp Co LLC – Berry Tincture, 1oz/1000mg

    FG003164

    BC Hemp Co LLC – Natural Tincture, 1oz/1000mg

    FG003318

    Goodness Gurus – Berry Tincture, 1oz/500mg

    FG003236

    Goodness Gurus – Spearmint Tincture, 1oz/500mg

    FG003234

    Goodness Gurus – Spearmint Tincture, 1oz/1000mg

    FG003238

    Goodness Gurus – Spearmint Tincture, 1oz/1500mg

    FG003237

    Herbzeedy LLC – Natural Tincture, 1oz/500mg

    FG003122, FG003123

    Herbzeedy LLC – Natural Tincture, 1oz/1500mg

    FG003121

    Javan Anti Aging – Spearmint Tincture, 1oz/300mg

    FG003283

    Pathway to Wellness – Natural Tincture, 1000mg/30ml

    FG003151

    The Spiffy Piff – Berry Tincture, 1oz/300mg

    FG003277

    The Spiffy Piff – Spearmint Tincture, 1oz/300mg

    FG003276

    Recovery ReLeaf – Vanilla Tincture, 1oz/1000mg

    FG003133

    Acadia Farms – Canadian Maple Tincture, 1oz/300mg

    FG003181

    Acadia Farms – Spearmint Tincture, 1oz/300mg

    FG003177

    Pet Consumption (White Label)

    Herbal Renewals – Cat Tincture, 1oz/200mg

    FG003213

    Herbal Renewals – Pet Blend, 1oz/200mg

    FG003223, FG003310

    Barkley Bistro – Dog Tincture, 1oz/200mg

    FG003145

    A Clean Choice – Cat Tincture, 1oz/200mg

    FG003117

    A Clean Choice – Cat Tincture, 500mg/1oz.

    FG003118

    A Clean Choice – Dog Tincture, 1oz/200mg

    FG003116

    A Clean Choice – Dog Tincture, 500mg/1oz.

    FG003115

    BC Hemp Co LLC – Pet Tincture, 1oz/200mg

    FG003165

    Boost IV Hydration, LLC – Dog Tincture, 1oz/200mg

    FG003270

    Acadia Farms – Pet Blend, 1oz/200mg

    FG003176

    How the company learned of this situation: The Company was recently advised by the Florida Department of Health of the presence of elevated heavy metals (lead) in some of its products. In response to this information, the Company undertook an investigation and determined that the issue related to graduated droppers provided by a third-party packaging supplier.

    Exposure to lead could present physical signs and symptoms including, pain, paresthesia/muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis or kidney damage.

    In response and in conjunction with the regulatory authorities, the Company:

    1. issued a voluntary nationwide recall of the affected products, providing every customer with replacement products at no cost to the customer; and
    2. retained a replacement third-party packaging supplier for all replacement and future products.
    3. Discontinue use of graduated droppers in the future.

    Prior to notifying customers of this recall, MHR Brands had not received any reports of adverse health effects regarding the recalled products. Consumers should contact their physician or healthcare provider if they experience any symptoms that may be related to using the products being recalled. Consumers should observe pets and contact their veterinarian as signs and symptoms of lead exposure in pets may be similar to those in humans.

    Immediately examine your inventory and quarantine product subject to this recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers should include a copy of this recall notification letter.

    Product Disposition: Return the product to the Company or destruction.

    This recall should be carried out to the consumer level. Your assistance is appreciated and necessary to complete this recall.

    MHR distributes nationally directly to consumers thorough internet sales and is currently notifying all customers about the ongoing recall directly. The Company also manufactures for other marketers and is notifying those customer of this issue and the identified LOTS urging return of the product to the Company or place of purchase for a free replacement or to contact MHR Brands at 844-300-5673 Mon.-Fri. 9am-5pm (EST) or by email at recall@mhrbrands.com.

  • Hostess Brands, LLC (“Hostess Brands”) is voluntarily recalling certain Hostess® Raspberry Zingers® because the product may develop mold prior to the best by date.This recall applies to the following Raspberry Zinger® products:
    Product Item UPC Batch Best By Date
    Hostess Raspberry Zingers (Multi-Pack fresh) 888109110604 H061224000 08/26/2020
    H061324000 08/27/2020
    H061424000 08/28/2020
    H061524000 08/29/2020
    Hostess Raspberry Zingers (Multi-Pack frozen) 888109110604 H061524000
    Hostess Raspberry Zingers (Single-Serve fresh) 888109010089 H061224000 08/26/2020
    H061324000 08/27/2020
    H061424000 08/28/2020
    Hostess Raspberry Zingers (Single-Serve frozen) 888109010089 H061424000
    H061524000
    Hostess Raspberry Zingers (Single-Serve grocery 3 count) 888109010089 H061224000 8/26/2020

    The products were sold to mass merchandisers, grocery stores, distributors, dollar and discount stores, and convenience stores throughout the United States.

    Consumers who have purchased the affected product are urged to discontinue consumption and contact the place of purchase about returning them for a full refund.

    This recall does not affect any other Hostess Brands products.

    Consumers with questions may contact 1-800-483-7253 Monday through Friday from 8:30 am to 4:30 pm Central Time.

    Hostess Brands, LLC

    Hostess Brands, LLC is headquartered in Lenexa, Kansas and operates bakeries in Emporia, Kansas, Chicago, Illinois, Columbus, Georgia, Indianapolis, Indiana and through its Voortman Cookies Limited subsidiary, Burlington, Ontario.

    For more information about Hostess products and Hostess Brands, please visit hostesscakes.com. Follow Hostess on Twitter: @Hostess_Snacks; on Facebook: facebook.com/Hostess; on Instagram: Hostess_Snacks; and on Pinterest: pinterest.com/hostesscakes.

  • Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed.Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related. All lots/serial numbers, not yet implanted, of the following models are in the scope of the correction:
    U.S. Model Numbers EU Model Numbers Rest of World Model Numbers
    TV-AB2080-J, TV-AB2380-J,
    TV-AB2680-J, TV-AB2980-J,
    TV-AB3480-J
    TV-AB2080-I, TV-AB2380-I,
    TV-AB2680-I, TV-AB2980-I,
    TV-AB3480-I
    TV-AB2080-J, TV-AB2380-J,
    TV-AB2680-J, TV-AB2980-J,
    TV-AB3480-J, TV-AB2080-I,
    TV-AB2380-I, TV-AB2680-I,
    TV-AB2980-I, TV-AB3480-I

    In addition to new information as to the root cause of leaks, the May 2020 correction notice also contained information regarding the incidence of aneurysm related complications and the lack of long-term sequelae following underfilling of the polymer rings caused by a polymer leak.

    The lifetime present rates of systemic clinical harms are tabulated below. These rates are based on voluntary complaint reporting and units sold, which may underestimate the true rate on a per-patient basis and contain less information than would be typical of an analysis from a clinical trial, as such some data are incomplete. The May 2020 analysis uses a different methodology than was previously used in the 2018 and 2020 correction notices, where the most severe systemic clinical harm was presented for each patient and, therefore, the number of clinical harms was equal to the number of patients.

    In contrast, the analysis for the May 2020 correction notice (shown below) includes more than one clinical harm per patient, if reported; therefore, the number of clinical harms exceeds the number of patients, meaning these data are not directly comparable with those presented in previous correction notices.

    Systemic Response to Polymer Leak Current lifetime rate (31 Lifetime rate of August 2018
    August 2015 to 29 May 2020)
    When prior FSN was issued (31 August 2015 to 30 June 2018)
    Death
    (quantity events)
    0.04% (5/12763) 0.04% (3/7285)
    Multi-organ failure1, cardiac arrest, neurological complication2
    (quantity events)
    0.11% (14/12763) 0.12% (9/7285)
    Local tissue necrosis3
    (quantity events)
    0.12% (15/12763) 0.12% (9/7285)
    Prolonged hemodynamic instability4
    (quantity events)
    0.16% (20/12763) 0.16% (12/7285)
    Transient hemodynamic instability
    (quantity events)
    0.71% (91/12763) 0.48% (35/7285)
    Spinal cord infarct
    (quantity events)
    0.01% (1/12763) 0.01% (1/7285)
    Total patients with an event 0.88% (112/12763) 0.65% (47/7285)

    1Includes dialysis, prolonged cardiac support, or liver failure;
    2Includes stroke;
    3Includes rash/skin necrosis (observed on the posterior lumbar area), muscle necrosis (para-spinal and in the lower limbs following an occurrence of
    compartment syndrome), renal, GI and lower limb ischemia.
    4Includes >24 hour critical care support.

    Two periprocedural patient deaths reported in the table occurred following complications after a polymer leak. One patient had an access site complication and one patient had an ischemic limb. It is difficult to establish to what degree the polymer leaks may have contributed to these deaths. Both are reported here for completeness.

    Figures in parentheses refer to the number of complaints received for each individual patient response and the total bifurcate units sold since product commercialization

    In addition to the systemic complications, 33 (0.27%) patients required an intervention for a Type 1a endoleak associated with a polymer leak and 9 (0.07%) patients required an iliac limb intervention due to underfilling of the polymer channel associated with a polymer leak.

    “Endologix is committed to replacing Ovation iX with the recently FDA-approved ALTO graft by the end of October 2020. ALTO is technically easier to implant and has been designed to improve acute outcomes, while retaining the unique durability of the Ovation platform,” commented John Onopchenko, Chief Executive Officer of Endologix. “Importantly, ALTO incorporates design and manufacturing changes that are intended to eliminate the areas of material weakness associated with polymer leaks. We believe ALTO should meaningfully reduce the incidence of polymer leaks. We look forward to receiving approval for ALTO in the EU, where the graft is in the final stages of CE Marking review.”

    “Ovation iX is differentiated from traditional devices for endovascular aneurysm repair (EVAR) through the use of liquid polymer. This technology presents many advantages, including its low-profile graft design with a durable, customized, anatomically adaptive aortic seal. However, it also presents the potential disadvantage of polymer leaks, as addressed in our recent safety communication,” said Matt Thompson, MD, Chief Medical Officer at Endologix. “In the transition to ALTO, physicians may be considering when to select Ovation iX for their patients given the root cause of polymer leaks. Certain patient cohorts, including women, patients with challenging access, patients needing fast-track EVAR, and patients with poor predicted durability using traditional EVAR grafts, may derive incremental clinical benefit from the design features of Ovation iX, as established by existing clinical evidence.”

    To clarify the decision-making process, Endologix has updated the labelling of the Ovation iX platform with the following warning: “Polymer leaks are a unique potential risk of the Ovation iX device platform that have been reported post-market. The complications of polymer leakage into the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks and iliac limb complications that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the Instructions for Use.”

    Consumers and physicians with questions may contact the Company via telephone at +1 800-983-2284. or via e-mail at customerservice@endologix.com

  • To be in compliance with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug claims stating the product(s) can diagnose, cure, mitigate, treat or prevent disease. The recalled drug products are misbranded and deemed unapproved drugs based on labeling claims which could result in a delay of appropriate treatment by a healthcare provider. Because these products are unapproved, their safety and efficacy have not been established. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products.The products included for recall are:
    Tenadam Herb Flax Seed Oil & Honey Blend Mitmitta (Cayenne Pepper)
    Spiced Tea Bitter Kola (Arogbo) Mahogany Bark
    Nigerian Moringa Leaf Powder Jamaican Bissy Powder Chaney Root
    Jamaican Turmeric Ghanian Black Spice Cerasee Bay Leaves, Mango Bark
    Bitter Wood Piss A Bed Asthma
    Devil Horsewhip White Pond Lily Blood Pressure
    Mango Leaf Purple Sage Heart
    Red Water Grass Quassia Wood Worms and Parasites
    Sarsaparilla Trumpet Leaf Flu-Allergies /HayFever
    Marsh Marigold White Jointa Arthritis
    Sea Moss/Irish Moss White Sage Axum Traditional Ethiopian Honey Beverage
    Dog Blood Guinea Hen Weed Black Sage
    Guava Leaf Sundial Cassava Meal Black Wiss
    Jack in the Bush Cocoa Balls Cinnamon
    King of the Forest African Fever Bush Palo De Brazil
    ETHIOPIAN ABISH (FENNUGREEK SEED PWD.) Mojo Bush Broom Weed
    Ethiopian Traditional Talba (Flaxseed Meal Cereal) Blood Leaf Bread Nut
    Fever Grass Wood & Root Tonic Jamaican and Tropical Raw Honey
    Jamaican Milk Wiss Koromantee Hemp Seed Oil
    Spanish Needle Ashanti Talibah’s Tooth Powder and Ethiopian Coffe
    Fig Leaf African Manback Tonic Blue Vervain
    Diabetics Pimento

    All products used as a Sundial Herbs can be identified by the “Sundial” label with brown glass bottles, boxes, Ziploc bags and paper bags with clear viewing windows. This was distributed state or nationwide via the Sundial Herb website (External Link Disclaimerhttp://sundialherbs.com/sundial/External Link Disclaimer)External Link Disclaimer, or any other website or store pick up at 3609 Boston Road, Bronx, New York. Please contact Sundial Herbs to schedule return orders for proper disposal and destruction of the products.

    The Sundial Herb company is halting product distribution of all products on their website and in their store location. Sundial Herbs recommends stopping use of these recalled products. No illnesses have been reported to date. However, if consumers have problems that may be linked to Sundial Herbs they should contact a Doctor immediately.

    Your immediate action, and response, is required. For questions or assistance in carrying out the request, please call Sundial (718) 798-3962.

  • Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protein Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in daily gains, icterus, partially cirrhotic livers and hemoglobin-stained kidneys. Occasionally, death occurs in copper-toxic sheep.This recall relates only to Ultralyx 12% Protein Sheep with the following batch numbers printed on the package:
    PRODUCT NAME Batch/Lot# Item No./Product No. Package Info.
    Ultralyx 12% Protein Sheep HB01679401 24419 50# Block

    Customers are asked to remove all product matching this batch number from distribution and inventory and discontinue feeding it immediately.

    No other batch number or other Ridley Block Operations products are involved in this voluntary recall. Of the batch of twenty blocks included in the recall, two blocks remain in the marketplace.

    Ridley Block Operations will continue to work closely with the Food and Drug Administration throughout the recall process. Our representatives are in direct communication with our customers to ensure the proper identification and removal of the impacted products.

    For guidance on affected product inventory or any other questions, customers may contact Ridley Block Operations Customer Service at 1-606-849-2170 (Monday – Friday, 8:00 a.m. – 4:30 p.m. ET).

  • Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.Granules’ test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batches distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market.Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 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 and found in water and foods, including meats, dairy products, and vegetables.Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets USP, 750 mg lots subject to the recall is identified in the table below.Metformin Hydrochloride Extended-Release Tablets USP, 750 mg

    NDC

    Bottle Count

    Lot/Expiration

    70010-492-01 100 count bottles 4920003A/May-21
    4920004A/Jun-21
    4920005A/Jun-21
    4920009A/Nov-21
    4920010A/May-22
    4920011A/Jun-22
    4920012A/Jun-22
    4920013A/Jul-22 4920014A/Jul-22
    4920015A/Aug-22
    4920016A/Jan-23
    70010-492-05 500 count bottles 4920005B/Jun-21

    The affected Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, lots were distributed nationwide in the USA directly to Distributors, and Retailers. Granules Pharmaceuticals, Inc. is in the process of notifying its distributers and customers affected by this recall via mail (FedEx standard overnight) by mailing a recall notification letter and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

    Customers and patients with questions regarding this recall or wishing to return product may contact Inmar Pharmaceutical Services product recall processor to obtain instructions and a return kit for returning their medication:

  • update –Garland Ventures Ltd of Garland, Texas is voluntary recalling 1095 cases of Five Cheese Stuffed Shells trays because they have the potential to be contaminated with 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 recalled “Five Cheese Stuffed Shells” was distributed nationwide in limited number of retail stores.The product “Five Cheese Stuffed Shells” comes in 10.76 ounces containing shells with marinara sauce, mozzarella cheese and parsley, and packed in aluminum foil container with clear lid marked lot# F080SS/F090SS on the bottom of label.No illnesses have been reported to date in connection with this problem.The potential for contamination was noted after samples tested through certified laboratory revealed the presence of Listeria monocytogenes in “Five Cheese Stuffed Shells”. Garland Ventures Ltd ceased the further production and distribution of product immediately.Consumers who have purchased 10.76 ounce trays of “Five Cheese Stuffed Shells” are urged to return them to the place of purchase for full refund. Consumers with quest
  • Norpac Fisheries Export is recalling all fresh shrimp poke distributed in the Hawaiian Island between May 11, 2020 and June 25, 2020 because it has potential to be contaminated with 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.Product was distributed in Hawaii on The Big Island, Maui, Oahu, and Kauai through its retail customers, specifically Safeway Stores.Any fresh shrimp poke purchased from their stores from May 11th, through June 25, 2020 would be potentially contaminated.Shrimp poke is distributed as pre-mixed in plastic pouches and go to service counter and then dishes out in various weight increments into a “deli cup”. This is a photo of product and label.“No illnesses have been reported to date.”We became aware of this problem during our routine Food Safety monitoring procedures, as we perform laboratory analysis of our work areas, equipment, surfaces, drains, raw materials and completed product. As a result of our routine random product and materials testing, we tested the shrimp used to make the shrimp poke, by having a sample sent to an independent lab for analysis. The results were received June 25, 2020 indicating a positive result for Listeria monocytogenes. We are proceeding under the cautious assumption that all of the shrimp from our supplier is contaminated.Our company has ceased the production and distribution of the product using this shrimp, as the FDA and the company continue their investigation as to the exact source of the problem.Consumers who have purchased Fresh Shrimp Poke are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-808-842-3474 Mon – Fri 8:00am. – 5:00pm. (HST, Hawaii standard time).
  • Garland Ventures Ltd of Garland, Texas is voluntary recalling 1095 cases of Five Cheese Stuffed Shells trays because they have the potential to be contaminated with 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 recalled “Five Cheese Stuffed Shells” was distributed nationwide in limited number of retail stores.

The product “Five Cheese Stuffed Shells” comes in 10.76 ounces containing shells with marinara sauce, mozzarella cheese and parsley, and packed in aluminum foil container with clear lid marked lot# F080SS/F090SS on the bottom of label.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after samples tested through certified laboratory revealed the presence of Listeria monocytogenes in “Five Cheese Stuffed Shells”. Garland Ventures Ltd ceased the further production and distribution of product immediately.

Consumers who have purchased 10.76 ounce trays of “Five Cheese Stuffed Shells” are urged to return them to the place of purchase for full refund. Consumers with questions may contact Bob Cocat anytime at 972-795-5313.