Drug product
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
D-1431-2019
Product summary
- Event
- Event 82863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,015 cartons
- Official record key
drug-enforcement:D-1431-2019
Official wording
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information: Lot, expiry: Lot 179049, exp 12/31/2019; Lot 182571, exp 8/31/2020
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
GMP Deviations