Drug product
Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
D-1447-2019
Product summary
- Event
- Event 82827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 113,304 90-count bottles
- Official record key
drug-enforcement:D-1447-2019
Official wording
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Code information: Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations