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/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
Source: FDA

#drugs #blood #us #sugar

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manufacturing practice (cGMP) requirements. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.

The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Region: USA. Quantity: 6,954.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Canada. Quantity: 3,651

Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it. Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone.

Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.

Company name: Honeywell Safety Products USA
Brand name: Fendall 2000
Product recalled: Non-Sterile Eyewash Cartridge
Reason of the recall: Non-compliance with current good manufacturing practice (cGMP) requirements.
FDA Recall date: April 05, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/honeywell-safety-products-usa-inc-issues-voluntary-worldwide-recall-honeywell-fendall-2000-non
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AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 … See More
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Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP. Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC. Consumers that have product which is being recalled should stop using the product and return it to place of purchase.

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

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: AvKARE, LLC
Brand name: AVpak
Product recalled: Atovaquone Oral Suspension, USP 750mg/5mL
Reason of the recall: Potential Bacillus cereus contamination
FDA Recall date: April 01, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due
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Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating … See More
inside of the vial.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label). The product label is as shown in the image below.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of 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.

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Company name: Eugia US LLC
Brand name: Eugia US LLC
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FDA Recall date: March 28, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection
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Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can … See More
result in an over-potent dosing regimen. The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

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Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
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Company name: Amneal Pharmaceuticals, LLC.
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Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution
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Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to … See More
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The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
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Recent Interesting Reports

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/safety/recalls-market-withdrawals-safety-alerts/adm-animal-nutrition-recalls-select-pen-palsr-chicken-feed-moormans-showtec-swine-feed-ampt-cattle
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Fullfillment house in FL., Tampa, Florida 33675, USA

2 weeks ago reported by user-mctt1139

My mother got a small red & white bottle of some sort of supplements today in the mail. Found 3-4 charges that she never authorized, the package has no address except for the ! PO Box 5708 Tampa fl & zip code. I went on an app … See More
called AfterShip & put in the tracking # & it showed when the label was created. currently trying to figure out which charge goes to this package if there is one. Please check your bank accounts!! If you need help finding the dates, download AfterShip (it’s FREE.) & type in the tracking # & it can show you when the label was created atleast so you have that sort of time frame to look for if they charged you!
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