Drug recall D-1451-2019
Product
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
Reason for recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots and codes
Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20.
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 13,564 25-count bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 6, 2019
- Terminated
- September 16, 2021
Related products
- Methylprednisolone – drug information
- NDC 68382-917 Methylprednisolone · Methylprednisolone 8 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-918 Methylprednisolone · Methylprednisolone 16 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-916 Methylprednisolone · Methylprednisolone 4 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-919 Methylprednisolone · Methylprednisolone 32 mg/1 · Zydus Pharmaceuticals USA Inc.