Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.
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. The presence of NDMA above acceptable levels represents a significant health risk, though no specific injuries or deaths are reported in the source text.
Plain-English summary
Nostrum Laboratories, Inc. is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles. The product is prescription-only and was distributed nationwide. The specific NDC number is 29033-055-01.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the detection of the impurity N-Nitrosodimethylamine (NDMA) was found above the acceptable intake level. NDMA is a potential carcinogen that can be present in certain pharmaceutical products.
Consumers with this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The affected lots are identified by the codes MET100201 and MET100401, with an expiration date of 05/2022.
The recalled product
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
- Manufacturer
- Nostrum Laboratories Inc
- Category
- Drug — Prescription Medication
- Affected units
- 20,872
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- MET100201
- MET100401 EXP 05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nostrum Laboratories Inc 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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