Recalls / Class II
Class IID-0626-2017
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.
- 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 #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Why it was recalled
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Recalling firm
- Firm
- GlaxoSmithKline, LLC
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1011 N Arendell Ave, N/A, Zebulon, North Carolina 27597-2309
Distribution
- Quantity
- 593,088 inhalers
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-03-22
- FDA classified
- 2017-03-31
- Posted by FDA
- 2017-04-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0626-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.