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FDAFDA · Food and drugs·Recall number D-1428-2012

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.

Published August 8, 2012 · Recall initiated: March 14, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Zydus Pharmaceuticals USA Inc
Distributor
Nationwide
Lot
Lot #: ML9605 Exp. 10/2013
Risk classification
Class II
Area (FDA)
drug
Country
United States

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