Recalls / Class II
Class IID-1666-2012
Product
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch 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 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13
Why it was recalled
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Recalling firm
- Firm
- GlaxoSmithKline Inc
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, P.O. Box 1217, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 1,412,566 inhalers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-26
- FDA classified
- 2012-08-28
- Posted by FDA
- 2012-09-05
- Terminated
- 2014-09-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1666-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.