Recalls / Class III
Class IIID-0330-2021
Product
Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608
- 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, Exp. 8/31/2022; 20L0026P, Exp. 9/30/2022
Why it was recalled
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Recalling firm
- Firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 379 Van Ness Ave Ste 1403, N/A, Torrance, California 90501-7211
Distribution
- Quantity
- N/A
- Distribution pattern
- Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
Timeline
- Recall initiated
- 2021-03-19
- FDA classified
- 2021-04-12
- Posted by FDA
- 2021-04-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0330-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.