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Baxter International Inc. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg - recalled due to N-Nitrosodimethylamine (NDMA), USA

3 years ago source www.fda.gov

Recall notice

United States

Company name: Baxter International Inc.
Brand name: Granules
Product recalled: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
Reason of the recall: N-Nitrosodimethylamine (NDMA)
FDA Recall date: July 06, 2020
Recall details: Company Announcement 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
Check the full recall details on www.fda.gov
Source: FDA

#drugs #blood #us #sugar

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ADM Animal Nutrition announced that specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine. ADM (NYSE: ADM), is recalling the following products: Pen Pals® Chicken Starter-Grower 25-lb bag (Product No 70009ACF46); Pen Pals Chicken … See More
Starter-Grower 50-lb bag (Product No. 70009AAA44); Pen Pals Chicken Starter-Grower 25-lb case (Product No. 70009AAABE); MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bag (Product No 21256CVWE4); MoorMan's Show-Tec Burst Starter with DFCTC/DEN 50-lb. bag (Product No: 24320AYWE4); ShowTec BB 18 BMD 50-lb. bag (Product No. 18241AGNE4); ShowTec 14.5/6 BMD 50-lb. bag (Product No. 14560AGN); AMPT-A CTC/IGR 50-lb. bag (Product No. 54229XNK); ShowTec Hi Fat 18 BMD 50-lb. bag (Product No. 18007AGN); Seniorglo 50-lb. bag (Product No. 10130AB) and MotivAte 12-15 DEN 50-lb. bag (Product No. 12286CVW). One customer reported chicken deaths related to consumption of the Pen Pals Chicken Starter-Grower 25-lb bags.

The lot number for the Pen Pals Chicken Starter-Grower 25-lb bags involved in this recall is Lot 507650QN. This product may contain elevated levels of calcium and phosphorus, which could lead to leg deformities, trouble standing and walking, and can be fatal to chickens. This product was distributed between Feb. 29, 2024 and March 8, 2024, and could have been purchased through distributors in Iowa and Missouri.

The lot number for the Pen Pals Chicken Starter-Grower 50-lb bags and Pen Pals® Chicken Starter-Grower 25-lb case involved in this recall is Lot 506942QN. These products may contain elevated levels of magnesium, which can cause bone deformities, slow growth rate, watery feces and can be fatal to chickens. These products were distributed between Feb. 28, 2024 and March 14, 2024, and could have been purchased through distributors in Missouri, Ohio, South Carolina, Iowa, California and Oregon.

The lot number for the MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bags involved in this recall is Lot 506664QN. This product may contain increased levels of sodium and chloride, which can lead to reduced feed intake, thirst and diarrhea. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the MoorMan’s ShowTec Burst Starter w/DF CTC/DEN 50-lb. bags involved in this recall is Lot 506640QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the ShowTec BB 18 BMD 50-lb. bags involved in this recall is Lot 506939QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in California, Illinois, Arizona, Missouri, and Iowa. The lot number for the ShowTec 14.5/6 BMD 50-lb. bags involved in this recall is Lot 507900QN. This product may contain increased levels of calcium, which could cause reduced feed intake and feed conversion. This product was distributed between March 8, 2024, and March 18, 2024, and could have been purchased through distributors in Iowa.

The lot number for the AMPT-A CTC/IGR 50-lb. bags involved in this recall is Lot 507828QN. This product may contain increased levels of sodium, which could cause loose stools and central nervous system issues. This product was distributed on March 1, 2024, and could have been purchased through distributors in Missouri.

The lot number for the ShowTec Hi Fat 18 BMD 50-lb. bags involved in this recall is Lot 505791QN. This product may contain increased levels of magnesium and calcium, which could cause reduced feed intake and feed conversion. This product was distributed between Jan. 26, 2024, and Feb. 7, 2024, and could have been purchased through distributors in Iowa, Oregon and California.

The lot number for the Seniorglo 50-lb. bags involved in this recall is Lot 505426QN. This product may contain increased levels of calcium, which could cause weight loss and the animal to become weak and listless. This product was distributed between Jan. 24, 2024, and Feb. 1, 2024, and could have been purchased through distributors in Missouri, Illinois, Ohio, Tennessee as well as from ADM locations in Glencoe, Minn., Springfield, Mo. and Dublin, Texas.

The lot number for the MotivAte 12-15 DEN 50-lb. bags involved in this recall is Lot 507330QN. This product may contain increased levels of calcium and phosphorus, which could cause reduced feed intake and feed conversion This product was distributed on Feb. 27, 2024, and March 4, 2024, and could have been purchased from ADM locations in Glencoe, Minn. and Columbus, Neb. After receiving a customer complaint related to swine refusing to eat feed from a single lot of MoorMan’s ShowTec Sale Burst w/DF DEN, ADM immediately investigated and discovered that the company’s animal feed manufacturing facility in Quincy, Illinois, experienced an equipment failure issue that impacted ingredient distribution in the plant.

The company initiated the recall once it was confirmed that these specific lots could contain harmful levels of calcium, phosphorus, magnesium sodium, and/or chloride. ADM has been in direct contact with the customers and distributors involved in this recall, and all product has been removed from retail shelves.

The lot number can be found at the bottom of the label. Customers who have purchased the recalled feed should immediately stop using it and return it to their distributor or directly to ADM Animal Nutrition for a full refund.

Company name: ADM Animal Nutrition
Brand name: Multiple Brand Names
Product recalled: Chicken Feed, Swine Feed, Cattle Feed, Horse Feed
Reason of the recall: Specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine.
FDA Recall date: April 01, 2024

Source: www.fda.gov
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