D-1666-2012 Class II Terminated
FDA drug recall D-1666-2012 was initiated by GlaxoSmithKline Inc on Jul 26, 2012 and is designated Class II. Reason for recall: Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. The recall status is terminated (terminated Sep 4, 2014). Affected quantity: 1,412,566 inhalers.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 5, 2012
- Initiation Date
- Jul 26, 2012
- Termination Date
- Sep 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,412,566 inhalers
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
Reason for recall
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Distribution pattern
Nationwide
Code information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1666-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026