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Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap...

FDA Recall #D-0056-2021 — Class II — October 8, 2020

Recall #D-0056-2021 Date: October 8, 2020 Classification: Class II Status: Ongoing

Product Description

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

Reason for Recall

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

Recalling Firm

Denton Pharma, Inc. — North Blenheim, NY

Classification

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

Product Type

Drugs

Product Quantity

N/A

Distribution

Indiana - Nationwide.

Code Information

N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021

Status

Ongoing

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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