April 2015 FDA Recall Drug by Cipla Limited
D-1078-2015 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Cipla Limited on April 24, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1078-2015

Reason for Recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Initiated
04-24-2015
Reported
05-20-2015
Quantity
140,625 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71133
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.
Cipla Limited
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2017
Product Description About Product Description
Full technical description of the product.
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.

Batch or Lot Expiration Information

Lot# : FA4022; Expiry: December 2015.