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Recall Observatory FDA recall evidence

Drug 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

D-0519-2016

December 03, 2015

Class II

Product summary

Firm
GlaxoSmithKline, LLC
Event
Event 72800
Status
Terminated
Classification
Class II
Quantity
128,704 Inhalers
Official record key
drug-enforcement:D-0519-2016

Official wording

Reason: Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

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

Distribution pattern: MS and VT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.