February 2019 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-0519-2019 - Failed Dissolution Specifications; 9-monthstability timepoint

This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on February 28, 2019 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; 9-monthstability timepoint. The product was distributed in Product was distributed to one customer who may have further distributed the product. and the recall is currently terminated.

Recall Number: D-0519-2019

Reason for Recall
Failed Dissolution Specifications; 9-monthstability timepoint
Initiated
02-28-2019
Reported
03-13-2019
Quantity
a) 3,072 bottles; b) 2,688 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82280
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.
Product was distributed to one customer who may have further distributed the product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-05-2020
Product Description About Product Description
Full technical description of the product.
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD

Batch or Lot Expiration Information

Lot# a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019