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Recall Observatory FDA recall evidence

Drug 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

D-1666-2012

July 26, 2012

Class II

Product summary

Firm
GlaxoSmithKline Inc
Event
Event 62799
Status
Terminated
Classification
Class II
Quantity
1,412,566 inhalers
Official record key
drug-enforcement:D-1666-2012

Official wording

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

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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