Recalls / Class II
Class IID-0519-2016
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
- Brand name
- Ventolin
- Generic name
- Albuterol Sulfate
- Active ingredient
- Albuterol Sulfate
- Route
- Respiratory (inhalation)
- NDC
- 0173-0682
- FDA application
- NDA020983
- Affected lot / code info
- Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Why it was recalled
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Recalling firm
- Firm
- GlaxoSmithKline, LLC
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 N Arendell Ave, N/A, Zebulon, North Carolina 27597-2309
Distribution
- Quantity
- 128,704 Inhalers
- Distribution pattern
- MS and VT
Timeline
- Recall initiated
- 2015-12-03
- FDA classified
- 2015-12-09
- Posted by FDA
- 2015-12-16
- Terminated
- 2016-10-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0519-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.