Recalls / Class II
Class IID-1449-2019
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
- Brand name
- Methylprednisolone
- Generic name
- Methylprednisolone
- Active ingredient
- Methylprednisolone
- Route
- Oral
- NDCs
- 68382-916, 68382-917, 68382-918, 68382-919
- FDA application
- ANDA206751
- Affected 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
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-06
- FDA classified
- 2019-07-01
- Posted by FDA
- 2019-06-26
- Terminated
- 2021-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1449-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.