Enforcement Report - Week of September 5, 2012
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Product Detail
| 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 |
|---|---|
| Recall Number | D-1666-2012 |
| Classification | Class II |
| 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 |
| Product Distributed Qty | 1,412,566 inhalers |
| Reason For Recall | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. |
Event Detail
| Event Id | 62799 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | GlaxoSmithKline Inc |
| City | Zebulon |
| State | NC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-26 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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