Recalls / Class II
Class IID-1451-2019
Product
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
- 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: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20.
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
- 13,564 25-count bottles
- 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-1451-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.