Marksans Pharma Limited: 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,

Is my product affected?

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 494

• Brand METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Check against the official notice below — it lists the full affected range.

What happened

Marksans Pharma Limited, manufacturing for Time-Cap Labs, Inc., is recalling Metformin Hydrochloride Extended Release Tablets USP 750 mg in 100-count bottles nationwide. The recall affects 368,976 bottles across multiple lot codes manufactured between October 2020 and April 2022 due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels, which represents a Current Good Manufacturing Practice (CGMP) deviation.

The source document does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Details from the source

Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Distribution: Nationwide Quantity: 368,976 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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