FDA Drug Recall Alert on 12/3/15
Date: 01/05/16
On December 3, 2015, Glaxo Smith Kline (GSK) voluntarily recalled two lots of Ventolin HFA aerosol inhalers.
Providers should note the following important details about this recall:
- Some inhaler canisters may not contain sufficient propellant to deliver the 200 doses that its label said it can provide through the end of its shelf life.
- All inhalers were manufactured at GSK’s plant in Zebulon, NC, which closed last summer.
- Only two lots are affected by this recall. Please see the table below for details:
| Product Description | Code Info | Classification | Reason for Recall | Product Quality | Recall Number |
|---|---|---|---|---|---|
| Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g, NDC 0173-0682-20* | Lot Numbers 5ZP1708, Exp. 12/2016 5ZP1951, Exp. 02/2017 | Class II | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of the shelf life. | 128.704 Inhalers | D-0519-2016 |
*Ventolin HFA Aerosol Inhalers Product Description
While Superior HealthPlan does not have access to prescription lot numbers, we do have information on members that filled prescriptions for this product. If you would like a specific list of your members who have filled this product, please contact the Superior Pharmacy department at 1-800-218-7453 x22080.
Providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Reports can be made by:
- Completing and submitting the report online: www.fda.gov/MedWatch/report
- Downloading the form (or calling 1-800-332-1088 to request a reporting form), then completing and mailing to the address on the form, or submitting by fax to 1-800-FDA-0178.
Please review the following resources for more information:
Ventolin HFA Aerosol Inhalers Frequently Asked Questions
For questions, please contact your local Provider Relations Representative.