D-0050-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 4, 2020
- Initiation Date
- October 11, 2020
- Termination Date
- February 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79/30 count blister cards
Product Description
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Distribution Pattern
Product was distributed to one customer in PA.
Code Information
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