Drug product
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
D-1450-2019
Product summary
- Event
- Event 82827
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1450-2019
Official wording
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Code information: lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations