Drug product
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
D-0492-2023
Product summary
- Event
- Event 91980
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 58 bottles, b) 6 bottles
- Official record key
drug-enforcement:D-0492-2023
Official wording
Reason: cGMP Deviations
Code information: Lot #: a) J0665197-120522, Exp. Date 12/31/2023; J0642497-082722, Exp. Date 09/30/2023 J0638552-080922, Exp. Date 08/31/2023. Lot #: b) B1808799-081622, Exp. Date 05/31/2024
Distribution pattern: RemedyRepack distributed product to consignees nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations