FDA 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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-10-02

Report date

2020-11-11

Termination date

2024-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vasco Da Gama, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0062-2021