Drug product
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
D-1452-2019
Product summary
- Event
- Event 82827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,664 90-count bottles
- Official record key
drug-enforcement:D-1452-2019
Official wording
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Code information: Lots: M713435 M713436 EXP Sep-19; M714191 EXP Oct-19; M808185 M808184 M808186 EXP May-20; M817634 M817635 EXP Nov-20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations