Recalls / Class III
Class IIID-0298-2021
Product
Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, 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 #: 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022
Why it was recalled
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
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
- 635,400 cartons
- Distribution pattern
- USA nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2021-02-19
- FDA classified
- 2021-03-04
- Posted by FDA
- 2021-03-10
- Terminated
- 2022-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0298-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.