Drug product
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
D-1432-2019
Product summary
- Event
- Event 82863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,698 cartons
- Official record key
drug-enforcement:D-1432-2019
Official wording
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information: Lot, expiry: Lot 172669, exp 05/31/2019; Lots 175872, 177086, exp 09/30/2019; Lot 179047, exp 12/31/2019; Lot 182584, exp 07/31/2020
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
GMP Deviations