Notes from the Nurse:
The health staff in both buildings have inspected all inhalers kept at school for the recalled lot numbers, and we are happy to report that none of the ventolin canisters have the numbers of the recalled models. Parents, be sure to inspect the inhalers that your children are allowed to self-carry, as we are not able to check the inhalers not kept in the health office.
Chris Eck RN, Joyce Peterson, RN, Nicole Pochran, RN
D-E School Nurses
GlaxoSmithKline (GSK) issued a voluntary Class II recall on April 4, 2017 for three lots of Ventolin® HFA 200D Inhalers from U.S. hospitals, pharmacies, retailers and wholesalers as a precautionary measure. It is not a consumer recall.
The lot numbers are:
A GSK spokesman spoke with AAFA and said the recall is due to some complaints about the overwrap, or pouches containing the inhalers, becoming inflated by leaking from the product. The leaking may cause the inhaler to deliver fewer doses than shown on the dose counter.
Patients are not being told to return the inhalers. If you have a question, call the company’s response center: 1-888-825-5249.
A Class II recall is one where "use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the U.S. Food and Drug Administration.
The company released a statement that said, “Though the overall benefit-risk assessment for Ventolin® HFA 200D Inhaler when used at prescribed doses remains favourable, in this situation, there is possible risk to patients of experiencing diminished bronchodilation in the setting of acute bronchospasm if reliant on a rescue inhaler that could potentially not deliver the stated number of actuations. GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this recall may cause."
If you need to fill a prescription for Ventolin HFA 200D, the voluntary recall should not affect pharmacy supplies.
Questions regarding a Ventolin HFA recall, contact GSK’s Customer Service Center at 1-888-825-5249, Monday-Friday, 8:30 am - 5:30 pm ET.
- No other lots are affected by the voluntary recall, meaning that, regardless of expiration date or doses indicated in dose counters, only inhalers in these two lots are affected.
- People with inhalers that match the expiration date on the Ventolin HFA inhaler, but not the lot number, are not impacted by the recall.
- People should call their pharmacy and/or doctor to ask about getting a new inhaler.