Recalls / Class II
Class IID-0050-2021
Product
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
- Affected lot / code info
- Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 79/30 count blister cards
- Distribution pattern
- Product was distributed to one customer in PA.
Timeline
- Recall initiated
- 2020-10-11
- FDA classified
- 2020-10-26
- Posted by FDA
- 2020-11-04
- Terminated
- 2021-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0050-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.