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Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: ...

FDA Recall #D-0050-2021 — Class II — October 11, 2020

Recall #D-0050-2021 Date: October 11, 2020 Classification: Class II Status: Terminated

Product Description

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00

Reason for Recall

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

Recalling Firm

RemedyRepack Inc. — Indiana, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

79/30 count blister cards

Distribution

Product was distributed to one customer in PA.

Code Information

Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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