Drug recall D-1453-2019

Class II Terminated reported Jun 26, 2019

Product

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

Reason for recall

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Lots and codes

Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21

Recall details

Recalling firm
Zydus Pharmaceuticals USA Inc, Pennington, NJ
Quantity
40872 25-count bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 6, 2019
Terminated
September 16, 2021

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