FDAFDA · Food and drugs·Recall number D-1356-2020
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Published July 1, 2020 · Recall initiated: June 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Manufacturer
- Marksans Pharma Limited
- Distributor
- Nationwide
- UPC
- 0349483624014
- Lot
- XP9004, exp 12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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