Note: As of May 16, 2017, GlaxoSmithKline expanded their recall. Additional lot numbers have been added below.

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:

• 6ZP0003 - expires April 2018
• 6ZP9944 - expires April 2018
• 6ZP9848 - expires March 2018
• 7ZP0634 - expires May 2018
• 7ZP0810 - expires May 2018
• 7ZP0990 - expires May 2018

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.

Originally posted on April 5, 2017