Recalls / Class II
Class IID-0058-2021
Product
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
- Brand name
- Metformin Hydrochloride Extended Release
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 72189-064, 72189-150
- FDA application
- ANDA090295
- Affected lot / code info
- Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recalling firm
- Firm
- Direct Rx
- Manufacturer
- direct rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 88 bottles
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2020-10-12
- FDA classified
- 2020-11-02
- Posted by FDA
- 2020-11-11
- Terminated
- 2021-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0058-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.