D-1450-2019 Class II Terminated
FDA drug recall D-1450-2019 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: N/A.
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
- N/A
Product Description
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Distribution Pattern
Nationwide in the USA
Code Information
lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20