FDA recall D-0330-2021

Asclemed USA Inc. dba Enovachem Pharmaceuticals · Class III · drug

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

Reason for recall

Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.

Distribution

Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.

Key facts

Status: Ongoing
Initiation date: 2021-03-19
Report date: 2021-04-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0330-2021