Recall Enforment Report D-0439-2017

Drug Recall Enforcement Report Class III voluntary initiated by Actavis Inc, originally initiated on 01-12-2017 for the product Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53 The product was recalled due to failed impurities/degradation specifications: product is out of specification for a known degradant.. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 76229 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0439-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide in the US What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Reason For Recall Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 164,844 units Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 02-01-2017
Recall Initiation Date 01-12-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 03-05-2018 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Actavis Inc
Code Info Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0591-3467-53; 0591-3468-53
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0591-3467Albuterol Sulfate Albuterol SulfateSolutionIntrabronchialActavis Pharma, Inc.Human Prescription Drug
0591-3468Albuterol Sulfate Albuterol SulfateSolutionIntrabronchialActavis Pharma, Inc.Human Prescription Drug