July 2012 FDA Recall Ventolin by Glaxosmithkline Inc
D-1666-2012 - Does Not Deliver Proper Metered Dose

This Class II drug recall was voluntarily initiated by Glaxosmithkline Inc on July 26, 2012 for the product Ventolin. The FDA reported the reason for recall as does not deliver proper metered dose. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1666-2012

Reason for Recall
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Initiated
07-26-2012
Reported
09-05-2012
Quantity
1,412,566 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62799
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.
GlaxoSmithKline 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-04-2014
Product Description About Product Description
Full technical description of the product.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20

Batch or Lot Expiration Information

Lot# Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13

Affected Packages Involved in this Recall

0173-0682-20 Ventolin Hfa
0173-0682-24 Ventolin Hfa