Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a carcinogenic impurity (NDMA) above acceptable levels.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level.
The affected product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ, and carries the NDC 53746-0178-90. The distribution pattern is listed as nationwide. Specific lot codes and expiration dates are provided in the structured product information, including lots manufactured between June 2020 and March 2021.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Prescription Medication
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Amneal Pharmaceuticals of New York, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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