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Nostrum Laboratories Metformin HCl Extended Release Tablets, USP 500 mg - recalled due to NDMA exceeds acceptable daily intake limit, USA

1 year ago

United States

Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 500 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: November 03, 2020
Recall details: Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

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. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-055-01. The affected Metformin HCl Extended Release Tablets, USP 500 mg lots are listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM5”. Metformin HCl Extended Release Tablets, USP 500 mg was distributed Nationwide to wholesalers.

- Metformin HCl Extended Release Tablets, USP 500 mg. NDC: 29033-055-01 (center panel). Lot Numbers - Expiry Dates: MET100201 - 05/2022. MET100401 - 05/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended-Release Tablets, USP 500 mg which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 Monday through Friday from 8am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on fda.gov

Source: FDA

101


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Purina Animal Nutrition is voluntarily recalling one lot of the following products for cattle livestock and for wildlife such as deer, antelope, and wild sheep due to the potential of elevated urea levels. The affected products include:

- Formula No. 376C . Description: Purina® PRECON Cattle Starter.... See More Item No.: 3006237-206. Package Info.: 50# Bag. Lot No. 1OCT18GOZ1. Intended Species: Cattle.

- Formula No. 30PR . Description: Purina® 4- SQUARE Stocker/Grower 14. Item No.: 46877. Package Info.: 50# Bag. Lot No. 1OCT15GOZ1. Intended Species: Cattle.

- Formula No. 30PF . Description: PURINA® 4- SQUARE® Breeder 20. Item No.: 47449. Package Info.: 50# Bag. Lot No. 1OCT15GOZ1. Intended Species: Cattle.

- Formula No. 528P . Description: PURINA® Antler Advantage Wildlife 16 ARS. Item No.: 3005417-201. Package Info.: Bulk Only. Lot No. OCTOBER 18,2021. Intended Species: Deer, Antelope, and Wild.

These products were distributed in Texas only.

Elevated urea levels can cause serious health issues and death in ruminant animals including cattle, deer, antelope, and wild sheep. Symptoms can include uneasiness, tremors, excess salivation, rapid breathing, incoordination, bloat, vomiting, twitching of ears and facial muscles, grinding of the teeth, abdominal pain, frequent urination, weakness, staggering, violent struggling and bellowing, and terminal spasms.

The elevated urea was discovered through internal plant review. Purina has not received any complaints or reports of illness or death to date. Should customers have any remaining feed from these lots, immediately discontinue feeding.

Customers can find the lot number on the sewing strip of each bag. Retailers are being contacted and told to immediately quarantine any remaining recalled product and notify customers who purchased the product. Customers who purchased this product should return remaining bags to their retailer

Company name: Purina Animal Nutrition
Brand name: Purina
Product recalled: Supplement feed for cattle livestock and for wildlife such as deer, antelope, and wild sheep
Reason of the recall: potential of elevated urea levels
FDA Recall date: October 27, 2021

Check the full recall details on fda.gov

Source: FDA
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106


MaryRuth’s, a leading omni-channel health and wellness brand that offers vitamins, minerals, and supplements for the entire family, today announced that, out of an abundance of caution, it is voluntarily recalling two lots of its liquid probiotic for infants (1oz) due to the possibility of contamination by... See More Pseudomonas aeruginosa.

Pseudomonas aeruginosa is a microorganism found in the environment that, if ingested, can cause infection in immunocompromised individuals or, rarely, in very young infants. P. aeruginosa infections in immunocompromised infants are generally limited to hospital settings. In such settings, there is the chance that the infant’s immature gut will not be able to prevent P. aeruginosa from gaining access to the blood, and from there it can disseminate elsewhere in the body, resulting in the possibility of serious adverse health consequences.

This recall only affects two lots of the product, Lot #100420218 and Lot #100520218, UPC barcode number 856645008587. Lot numbers are located on the side of the bottle and on the bottom of the outer container in which the product is sold. No other lots or any other MaryRuth’s products are affected by this recall. This product is distributed nationwide through Target, Amazon, and direct sales from the company’s website.

The company is asking consumers to throw away product from both affected lot numbers. The company discovered the potential issue with one of its manufacturing partners during routine laboratory testing.

The only product complaint the company has received with respect to the affected product lots was one report of temporary diarrhea in an older infant after consuming the product, which the company does not believe was related to the presence of the microorganism.

Company name: MaryRuth’s
Brand name: MaryRuth’s
Product recalled: liquid probiotic for infants
Reason of the recall: Potential contamination with Pseudomonas aeruginosa
FDA Recall date: October 29, 2021

Check the full recall details on fda.gov

Source: FDA
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101


Nutracap Holdings, LLC of Norcross, Georgia is voluntarily recalling various dietary supplements due to undeclared wheat, milk, soy and/or coconut on the labels. People who have an allergy or severe sensitivity to soy, milk, wheat, or coconut run the risk of serious or life-threatening allergic reaction if... See More they consume products containing soy, milk, wheat, or coconut.

On 11/4/2021 during an FDA inspection the firm was notified that their labels failed to disclose the presence of allergens on some of their products. The recalled products were shipped between June 4, 2020 through October 1, 2021 to distributors and retailers in Alabama, California, Florida, and Texas. There have been no illnesses reported to date.

The affected products are:

Brand: Boba Origin. Product: 100% Whey Protein Isolate. Flavor: Brown Sugar Milk, Tea, Undeclared milk, & soy. Size: 1 gallon plastic jar. Lot No. 2106263. Exp. 07/2023

Brand: Etedream. Product: Etegrow ISO. Flavor: Snicker Doodle, Undeclared milk. Size: 2gallon plastic jar. Lot No. 2106002. Exp. 06/2023


Brand: RAW. Product: Vegan Protein Flavor: Peanut Butter, Undeclared coconut. Size: 1gallon plastic jar. Lot No. 2108070, 2104340, 2102018, 2012304, 2010266, 2010102, 2007037/746, 2005132. Exp. 08/2023, 04/2023, 02/2023, 12/2022, 10/2022, 10/2022, 07/2022, 05/2022

Brand: Steel. Product: Veg-Pro Flavor: Cookies & Crème, Undeclared Wheat. Size: 64 ounce plastic jar. Lot No. 2109390, 2104333, 2011260, 2104007/1041, 2105059, 2011260/994. Exp. 09/2023, 04/2023, 11/2022, 04/2023, 05/2023, 11/2022

Brand: Vital Force. Product: PureISO. Flavor: Milk Chocolate, Cocoa, Undeclared milk. Size: 1gallon plastic jar. Lot. No. 2108191. Exp. 09/2023

Brand: Vital Force. Product: PureISO. Flavor: Creamy Peanut, Butter Vanilla, Undeclared milk. Size: 1gallon plastic jar. Lot No. 2109068. Exp. 09/2023

Lot numbers and expiration dates are found on the bottom of each container.

Retailers and distributors who have received any of these products should check inventory, immediately remove from sale and notify customers who purchased them of the recall.

This recall is being made with the knowledge of the Food and Drug Administration.

Company name: Nutracap Holdings, LLC
Brand name: Etedream, Vital Force, Raw, Boba Origin, Steel
Product recalled: Dietary Supplement Protein Powder
Reason of the recall: Undeclared wheat, milk, soy and/or coconut
FDA Recall date: November 09, 2021

Check the full recall details on fda.gov

Source: FDA
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5


The Procter & Gamble Company (NYSE: PG) is voluntarily recalling all lots with expiry through September 2023 of specific Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products sold in the United States, and listed in the table below, to the... See More consumer level due to the presence of benzene detected.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening. Based on exposure modeling and the cancer risk assessments published by the Environmental Protection Agency (EPA) (IRIS database), daily exposure to benzene in the recalled products at the levels detected in our testing would not be expected to cause adverse health consequences. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. To date, The Procter & Gamble Company has not received any reports of adverse events related to this recall and is conducting this recall out of an abundance of caution.

The affected products are used as antiperspirants and hygiene products and are packaged in aerosol cans. See the link below for Product names and UPC codes and images for further descriptions. They are recalling all lots with expiry through September 2023 of the products listed in the link below.

Company name: The Proctor & Gamble Company
Brand name: Old Spice Secret
Product recalled: Old Spice and Secret Aerosol Sprays
Reason of the recall: Due to the presence of benzene
FDA Recall date: November 23, 2021

Check the full recall details on fda.gov

Source: FDA
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101


CHICAGO, IL – November 19, 2021 - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.

Risk Statement: Intravenous... See More administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening. 

To date, Sagent has not received reports of any product complaints or adverse events associated with this issue. Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. 

Product: Levetiracetam Injection, USP / Lot Number: B0G85VB /Expiration Date: Jun-2022 / NDC Number: 25021-780-05 / Distribution Dates: May 2021 - August 2021.

Product: Levetiracetam Injection, USP / Lot Number: B0K88VA /Expiration Date: Sep-2022 / NDC Number: 25021-780-05 / Distribution Dates: March 2021 - November 2021.

Product: Levetiracetam Injection, USP / Lot Number: B0K89VA /Expiration Date: Sep-2022 / NDC Number: 25021-780-05 / Distribution Dates: August 2021 - November 2021.

Product: Levetiracetam Injection, USP / Lot Number: B1G194A /Expiration Date: Jun-2023 / NDC Number: 25021-780-05 / Distribution Dates: October 2021.

Product was distributed Nationwide from March to November  2021.

Company name: Sagent Pharmaceuticals, Inc.
Brand name: Sagent
Product recalled: Levetiracetam Injection
Reason of the recall: Lack of sterility assurance
FDA Recall date: November 22, 2021

Check the full recall details on fda.gov

Source: FDA
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Odor-Eaters®, owned by Blistex Inc., is voluntarily recalling a total of forty-one lots of two Odor-Eaters® spray products to the consumer level due to the presence of benzene. Internal testing identified low levels of benzene contamination in specific lots of these aerosol products.

Risk Statement: Benzene is... See More classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.

To date, Odor-Eaters® has not received any reports of adverse events related to this recall. The affected Odor-Eaters® spray products are used as antifungal and foot odor-reducing agents and are packaged in aerosol cans. See the link below for UPC, lot number and expiration dates. Refer to the image below for guidance on where to find the lot code details on the can. Forty-one lots of two Odor-Eaters® spray products (Odor-Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® Spray) are impacted by this voluntary recall, specifically the ones listed in the link below.

The products were distributed nationwide in the United States through various retailers. Consumers, distributors, and retailers that have product which is being recalled should stop using or selling these specific Odor-Eaters® spray products and dispose of them appropriately.

Company name: Odor-Eaters®, owned by Blistex Inc.
Brand name: Odor-Eaters®
Product recalled: Oder Eaters spray products
Reason of the recall: Due to the presence of benzene
FDA Recall date: November 17, 2021

Check the full recall details on fda.gov

Source: FDA
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101


Car crashes into utility pole, leaves more than 1,000 in New Bern without power

Source: wcti12.com
Source publication date: 2021 11 27 See Less
134


A Boil Water Advisory is now in effect for all customers of Hide-a-Way Hills , November 26th.

Source: twitter.com
Source publication date: 2021 11 26 See Less
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