FDA Recall D-0330-2021

Asclemed USA Inc. dba Enovachem Pharmaceuticals · Torrance, CA

Class III Ongoing 1882 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot #: 20K0043P, Exp. 8/31/2022; 20L0026P, Exp. 9/30/2022

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0330-2021
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
Recall initiated: 2021-03-19
Classified by FDA Center: 2021-04-12
FDA published: 2021-04-21
Recalling firm: Asclemed USA Inc. dba Enovachem Pharmaceuticals
Firm location: Torrance, CA

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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