Home / Recalls / Marksans Pharma Limited / D-1356-2020

D-1356-2020 Class II Terminated

Recalled by Marksans Pharma Limited — Vasco Da Gama, N/A

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