Drug product
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
D-1442-2019
Product summary
- Event
- Event 82827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 204 1000-count bottles
- Official record key
drug-enforcement:D-1442-2019
Official wording
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Code information: Lot: M714919, EXP Dec-19, M815081, EXP Aug-20, M900475, EXP Dec-20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations