Recalls / Class II
Class IID-1364-2020
Product
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
- Affected lot / code info
- J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020
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
- 144 bottles
- Distribution pattern
- Product was distributed to two medical clinics located in FL.
Timeline
- Recall initiated
- 2020-06-17
- FDA classified
- 2020-06-26
- Posted by FDA
- 2020-07-08
- Terminated
- 2024-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1364-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.