Drug recall D-1356-2020
Product
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
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots and codes
XP9004, exp 12/2020
Recall details
- Recalling firm
- Marksans Pharma Limited, Vasco Da Gama, N/A
- Quantity
- 11279 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 5, 2020
- Terminated
- September 7, 2023
Related products
- Metformin Hydrochloride Extended Release – drug information
- NDC 49483-624 Metformin Hydrochloride Extended Release · Metformin Hydrochloride 750 mg/1 · TIME CAP LABORATORIES, INC
- NDC 49483-623 Metformin Hydrochloride Extended Release · Metformin Hydrochloride 500 mg/1 · TIME CAP LABORATORIES, INC