Drug product
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
D-0496-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1,262 bottles, b) 95 bottles
- Official record key
drug-enforcement:D-0496-2023
Official wording
Reason: cGMP Deviations
Code information: Lot #: a) J0675206-011223, J0669260-121922, Exp. Date 01/31/2024; J0656820-103122, J0647161-091722, Exp. Date 09/30/2023 Exp. Date 11/30/2023; J0621491-052722, Exp. Date 06/30/2023; J0638138-080822, Exp. Date 08/31/2023, J0610887-041122, Exp. Date 04/30/2023. Lot # b) B1887315-100422, Exp. Date 02/28/2024; B1829906-083122, B1769715-071622, Exp. Date 09/30/2023; B1906605-101422, Exp. Date 02/28/2024; B1965118-111622, Exp. Date 02/28/2025.
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations