Drug product
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
D-0498-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,426 bottles
- Official record key
drug-enforcement:D-0498-2023
Official wording
Reason: cGMP Deviations
Code information: Lot #: a) J0659819-110922, Exp. Date 11/30/2023; J0649932-093022, J0649917-093022 Exp. Date 10/31/2023, B2010060-121222, Exp. Date 03/31/24 Lot #: b) B1708575-060122, Exp. Date 05/31/2023; B1879236-092922, Exp. Date 12/31/2023
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations