Recalls / Class II
Class IID-0077-2021
Product
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
- Affected lot / code info
- E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 99 bottles (9990 Extended Release Tablets)
- Distribution pattern
- Distributed to two physician's offices located in FL.
Timeline
- Recall initiated
- 2020-11-01
- FDA classified
- 2020-11-14
- Posted by FDA
- 2020-11-25
- Terminated
- 2024-05-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0077-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.