FDA Recall D-0626-2017

GlaxoSmithKline, LLC · Zebulon, NC

Class II Ongoing 3340 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

Quantity: 593,088 inhalers

Reason for recall

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

Recall record

Recall number: D-0626-2017
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: Nationwide in the USA and Puerto Rico
Recall initiated: 2017-03-22
Classified by FDA Center: 2017-03-31
FDA published: 2017-04-12
Recalling firm: GlaxoSmithKline, LLC
Firm location: Zebulon, NC

Drug identification

Brand name(s): VENTOLIN
Generic name(s): ALBUTEROL SULFATE
Manufacturer(s): GlaxoSmithKline LLC
NDC(s): 0173-0682
Route(s): RESPIRATORY (INHALATION)

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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