FDA-Drug2012-08-08Class II

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.

Zydus Pharmaceuticals USA Inc
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.

Sold states
Nationwide
Affected count
1176 Bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1428-2012

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