December 2015 FDA Recall Ventolin by Glaxosmithkline, Llc
D-0519-2016 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Glaxosmithkline, Llc on December 3, 2015 for the product Ventolin. The FDA reported the reason for recall as defective delivery system. The product was distributed in MS and VT and the recall is currently terminated.

Recall Number: D-0519-2016

Reason for Recall
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Initiated
12-03-2015
Reported
12-16-2015
Quantity
128,704 Inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72800
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, LLC
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.
MS and VT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-25-2016
Product Description About Product Description
Full technical description of the product.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20

Batch or Lot Expiration Information

Lot# s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017

Affected Packages Involved in this Recall

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