Drug product
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
D-1445-2019
Product summary
- Event
- Event 82827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,156 1000-count bottles
- Official record key
drug-enforcement:D-1445-2019
Official wording
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Code information: Lots: M706803, EXP Jun-19; M713438, EXP Oct-19; M801704, EXP Jan-20; M808306, EXP Jun-20; M812484, EXP Aug-20; M820264, EXP Dec-20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations