Drug product
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
D-1433-2019
Product summary
- Event
- Event 82863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,777 cartons
- Official record key
drug-enforcement:D-1433-2019
Official wording
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information: Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
GMP Deviations