D-1451-2019 Class II Terminated
FDA drug recall D-1451-2019 was initiated by Zydus Pharmaceuticals USA Inc on May 6, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. The recall status is terminated (terminated September 16, 2021). Affected quantity: 13,564 25-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2019
- Initiation Date
- May 6, 2019
- Termination Date
- September 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,564 25-count bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20.