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Metformin Hydrochloride Extended-Release Tablet - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA
3 years ago
United States
Company name: Teva Pharmaceuticals USA Inc.
Brand name: Actavis
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
Recall details: Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). 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 is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.
The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.
- NDC: 62037-571-01/ Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1329548A/ Expiration: 06/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1338302M/ Expiration: 10/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348968M/ Expiration: 10/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348969M/ Expiration: 11/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348970M/ Expiration: 10/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1376339M/ Expiration: 09/2021
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1323460M/ Expiration: 06/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1330919M/ Expiration: 06/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1338300A/ Expiration: 10/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1341135M/ Expiration: 12/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1391828M/ Expiration: 11/2021
- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333338M/ Expiration: 08/2020
- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333339A/ Expiration: 08/2020
- NDC: 62037-577-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count/ Lot Number: 1354471A/ Expiration: 02/2021
Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.
Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-initiates-voluntary-nationwide-recall-metformin-hydrochloride-extended
Source: FDA
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- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.
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Company name: Amneal Pharmaceuticals, LLC.
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Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024
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FDA Recall date: March 20, 2024
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Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.
Source: recalls-rappels.canada.ca/en/alert-recall/folic-acid-1mg-affected-lots-exceed-or-may-exceed-acceptable-intake-limit-n-nitroso See Less
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Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels 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.
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Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. Vials from the affected lot bear the attached label.
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Company name: Endo International, Par Pharmaceutical
Brand name: Par Pharmaceutical
Product recalled: Treprostinil 20mg/20mL Injection
Reason for the recall: Potential Presence of Silicone Particulate Matter
FDA Recall date: March 12, 2024
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For Lot number and expiry dates, you can visit the link below.
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Company name: Brassica Pharma Pvt. Ltd.
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FDA Recall date: February 26, 2024
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