Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
Reported: July 22, 2020 Initiated: July 7, 2020 #D-1383-2020
Product Description
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 95,886 bottles
- Distribution
- Product was distributed throughout the United States.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 95,886 bottles.
Why was this product recalled? ▼
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 22, 2020. Severity: Moderate. Recall number: D-1383-2020.
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