Key Takeaway
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. Penning by Zydus Pharmaceuticals USA Inc was recalled on March 14, 2012. The hazard: Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The...
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. Penning
Description
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.
Hazard / Reason
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.
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
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. Penning
DrugsCompany Information
Zydus Pharmaceuticals USA Inc
Pennington, NJ, United States
View all 91 recalls by Zydus Pharmaceuticals USA Inc →Distribution
Nationwide
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.