Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected 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 and involves the detection of a carcinogenic impurity (NDMA) above acceptable intake levels, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 6,540 bottles of Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals, Inc., in Baltimore, MD, and manufactured by Lupin Limited in Goa, India. The specific batch involved is # G901203 with an expiration date of 12/2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. The agency has classified this recall as Class II.
The product was distributed throughout the United States. Consumers and healthcare providers should check their inventory for the specific NDC 68180-336-07 and batch number G901203. If found, the product should be returned to the pharmacy or point of purchase for disposal or replacement.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 6,540
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)
- Batch # G901203
- exp. date 12/2020
UPCs (1)
- 0368180337072
Distribution
Distribution scope not specified by the agency.
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