Recalls / Class III
Class IIID-1205-2018
Product
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
- Brand name
- Methylprednisolone
- Generic name
- Methylprednisolone
- Active ingredient
- Methylprednisolone
- Route
- Oral
- NDCs
- 59746-001, 59746-002, 59746-003, 59746-015
- FDA application
- ANDA040189
- Affected lot / code info
- Lot # 17P0078, exp. date 12/2018
Why it was recalled
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 89,722 blister pack
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2018-08-27
- FDA classified
- 2018-09-21
- Posted by FDA
- 2018-09-26
- Terminated
- 2019-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1205-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.