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
Check against the official notice below — it lists the full affected range.
Zydus Pharmaceuticals USA Inc is recalling MethylPREDNISolone Tablets, USP 4 mg per tablet in 21-tablet dosepacks distributed nationwide in the USA. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving cross contamination with other products caused by a cleaning failure during manufacturing. The affected medication was manufactured in India and distributed by Zydus Pharmaceuticals USA Inc in Pennington, New Jersey.
The recall affects multiple lot numbers with expiration dates ranging from February 2020 through March 2021, including lots M800150, M803930, M806006 through M806011, M807299 through M807308, M807779, M807780, M808194 through M808198, M811092 through M811094, M811097, M811665 through M811667, M813781, M816286, M816288 through M816290, M817612 through M817616, M818315, M820619 through M820621, M901594 through M901597, and M903484. The recall record does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason for recall: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Distribution: Nationwide in the USA Quantity: N/A Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.