Reported Aug 8, 2012 · Terminated

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle
  • Manufactured byCadila Healthcare LTD. Ahmedabad, India
  • Distributed by
    • Zydus Pharmaceuticals USA Inc. Pennington
    • NJ 08534
    • NDC 68382-030-10
Lot codes and dates
  • Lot #: ML9605 Exp. 10/2013
Amount recalled
1176 Bottles

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 17, 2013 · Data as of Sep 19, 6:31 PM UTC

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