August 2018 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-1205-2018 - Failed Stability Specifications
This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on August 27, 2018 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.
Recall Number: D-1205-2018
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
08-27-2018
09-26-2018
89,722 blister pack
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States.
10-08-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Batch or Lot Expiration Information
Lot# 17P0078, exp. date 12/2018
