June 2022 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-1150-2022 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on June 10, 2022 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1150-2022

Reason for Recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Initiated
06-10-2022
Reported
06-22-2022
Quantity
3,216 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90415
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin 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 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

Batch or Lot Expiration Information

Lot# Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22