March 2021 FDA Recall Drug by Asclemed Usa Inc. Dba Enovachem Pharmaceuticals
D-0330-2021 - Labeling

This Class III drug recall was voluntarily initiated by Asclemed Usa Inc. Dba Enovachem Pharmaceuticals on March 19, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL. and the recall is currently ongoing.

Recall Number: D-0330-2021

Reason for Recall
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Initiated
03-19-2021
Reported
04-21-2021
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87548
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Asclemed USA Inc. dba Enovachem Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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