D-1356-2020 Class II Terminated
FDA drug recall D-1356-2020 was initiated by Marksans Pharma Limited on June 5, 2020 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level The recall status is terminated (terminated September 7, 2023). Affected quantity: 11279 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- June 5, 2020
- Termination Date
- September 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11279 bottles
Product Description
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
Distribution Pattern
Nationwide
Code Information
XP9004, exp 12/2020