Drug product
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
D-1434-2019
Product summary
- Event
- Event 82863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,643 cartons
- Official record key
drug-enforcement:D-1434-2019
Official wording
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information: Lot, expiry: Lot 176179, exp 05/31/2019; Lot 176616, exp 07/31/2019; Lot 178562, exp 09/30/2019; Lot 179947, exp 12/31/2019; Lot 182048, exp 04/30/2020; Lot 183136, exp 06/30/2020; Lot 184217, exp 08/31/2020
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
GMP Deviations