March 2017 FDA Recall Ventolin by Glaxosmithkline, Llc
D-0626-2017 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Glaxosmithkline, Llc on March 22, 2017 for the product Ventolin. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0626-2017
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
03-22-2017
04-12-2017
593,088 inhalers
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Batch or Lot Expiration Information
Lot# : 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
