Skip to content
Recall Observatory FDA recall evidence

Drug product

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

D-1449-2019

May 06, 2019

Class II

Product summary

Firm
Zydus Pharmaceuticals USA Inc
Event
Event 82827
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1449-2019

Official wording

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

Code information: Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations