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Recall Observatory FDA recall evidence

Drug 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.

D-0626-2017

March 22, 2017

Class II

Product summary

Firm
GlaxoSmithKline, LLC
Event
Event 76839
Status
Ongoing
Classification
Class II
Quantity
593,088 inhalers
Official record key
drug-enforcement:D-0626-2017

Official wording

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

Code information: Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification