Home / Recalls / Marksans Pharma Limited / D-0062-2021

D-0062-2021 Class II Terminated

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

Recall Details

Product Type: Drugs
Report Date: November 11, 2020
Initiation Date: October 2, 2020
Termination Date: February 21, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 368,976 bottles

Product Description

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

Distribution Pattern

Nationwide

Code Information

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