February 2021 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-0298-2021 - Labeling

This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on February 19, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0298-2021

Reason for Recall
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Initiated
02-19-2021
Reported
03-10-2021
Quantity
635,400 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87342
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
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.
USA nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-15-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022