Amneal Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling specific lots of 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 agency classification is FDA Class II, and the presence of NDMA impurity above acceptable intake levels in a prescription drug constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only. The recall is due to FDA analysis detecting the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level.
The affected product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ. The specific NDC number is 53746-0179-BULK. The recall covers lots with the following codes and expiration dates: HA01520A (1/31/2021), HA01620A (1/31/2021), HG01719A (7/31/2020), HG01819A (7/31/2020), HH09319A (8/31/2020), HH09419A (9/30/2020), HK07619A (10/31/2020), and HK07719A (10/31/2020).
The distribution pattern is listed as Nationwide. Patients and healthcare providers should check their inventory for these specific lot codes and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
- 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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