Reported Jul 8, 2020 · Terminated
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only,…
The Harvard Drug Group
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: The Harvard Drug Group · 17177 N Laurel Park Dr Ste 233 · Livonia, MI · 48152-3951
Is this the product you have?
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only
- Manufactured byApotex, Inc., Toronto, Ontario, Canada
- Manufactured forApotex Corp. Weston, FL
- Distributed byMajor Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
- Lot codes and dates
Lot T-02134exp 09/2020
- Amount recalled
- 1,906 Cartons
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
This product could cause temporary or reversible health problems — stop using it.
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