Status
Terminated
Drug Enforcement D-1666-2012
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Classification
Class II
Report Date
September 5, 2012
Termination Date
September 4, 2014
Product Information
- Product description
- 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
- Product quantity
- 1,412,566 inhalers
- Reason for recall
- Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- GlaxoSmithKline Inc
- Address
-
1011 North Arendell Ave, P.O. Box 1217
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1666-2012
- Event ID
- 62799
- Recall initiation date
- July 26, 2012
- Center classification date
- August 28, 2012
- 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
- More code info
- —