Recalls / Class II
Class IID-0385-2021
Product
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
- Affected lot / code info
- Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
Why it was recalled
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 147 bottles (14,700 extended release tablets)
- Distribution pattern
- Distributed to two physician consignees located in FL.
Timeline
- Recall initiated
- 2021-04-28
- FDA classified
- 2021-05-16
- Posted by FDA
- 2021-05-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0385-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.