Class II
Terminated
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
- Company
- Remedyrepack Inc.
- Recall Initiated
- October 11, 2020
- Posted
- November 4, 2020
- Recall Number
- D-0050-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 79/30 count blister cards
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Distribution
Product was distributed to one customer in PA.
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
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