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Recall Observatory FDA recall evidence

Drug product

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.

D-0793-2017

May 16, 2017

Class II

Product summary

Firm
GlaxoSmithKline, LLC
Event
Event 77329
Status
Ongoing
Classification
Class II
Quantity
562,883
Official record key
drug-enforcement:D-0793-2017

Official wording

Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate

Code information: Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18

Distribution pattern: Nationwide in the US and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification