Recalls / Class III
Class IIID-0752-2022
Product
Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
- 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 # 21 P0322, Exp. 01/2023
Why it was recalled
Subpotent
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 19,222 Bottles (100-count)
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-04-01
- FDA classified
- 2022-04-06
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0752-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.