Drug recall D-1666-2012

Class II Terminated reported Sep 5, 2012

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

Reason for recall

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Lots and codes

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

Recall details

Recalling firm
GlaxoSmithKline Inc, Zebulon, NC
Quantity
1,412,566 inhalers
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 26, 2012
Terminated
September 4, 2014

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