Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable intake 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 and involves the presence of a carcinogenic impurity (NDMA) above acceptable intake levels, which meets the criteria for a Severe rating due to significant health risk potential.
Plain-English summary
Nostrum Laboratories, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle (NDC: 29033-056-01). The recall involves 6,958 bottles of the prescription medication, which were distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was found to contain the impurity N-Nitrosodimethylamine (NDMA) at levels above the acceptable intake limit. The affected product is identified by the code MET200501 with an expiration date of 07/2022.
Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider for guidance on alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
- Manufacturer
- Nostrum Laboratories Inc
- Category
- Drug — Prescription Medication
- Affected units
- 6,958
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 (1)
- MET200501 07/2022
Distribution
Distributed nationwide across the United States.
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