Drug recall D-0062-2021
Product
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only 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 Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
Reason for recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots and codes
M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
Recall details
- Recalling firm
- Marksans Pharma Limited, Vasco Da Gama, N/A
- Quantity
- 368,976 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 2, 2020
- Terminated
- February 21, 2024
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