US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 14, 2012 (14 years ago)

Metformin Hydrochloride Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.

What was recalled

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.

Recalling firm
Zydus Pharmaceuticals USA Inc
NDC code
68382-030-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1428-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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