GlaxoSmithKline has added three more lots of its Ventolin inhalers to its recent recall, bringing the total to more than 1.1 million units.
According to a recent FDA Enforcement Report, the drugmaker this month voluntarily recalled the three lots, amounting to 562,883 of the inhalers used by patients with asthma or COPD to prevent bronchospasms. The class II recall again is because the company discovered an elevated number of units that were out of spec for leak rate.
The company in March had recalled three lots amounting to 593,088 inhalers. This brings the total to 1,155,971 units, which a GSK spokesperson pointed out amounts to about 4% of total US annual Ventolin volume. The inhalers were made at GSK’s plant in Zebulon, North Carolina.
GSK in late 2015 recalled nearly 130,000 Ventolin inhalers over a similar issue.
In an email Thursday, the GSK spokesperson said the extended voluntary recall "is due to product complaints relating to overly inflated overwraps or pouches". He said that could could indicate leaking, which may result in the inhaler delivering fewer doses than anticipated on the dose counter. The company again pointed out the recall is not to the consumer level, meaning patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level, so products are being removed from those channels.
“GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this extended voluntary recall may cause,” he said.
Ventolin continues to be a strong-selling product for GSK, which is adding capacity to its production line for the product. While GSK’s top-selling respiratory drug Advair turned in fading sales in 2016, Ventolin had a 23% jump to about $527 million, as a competitor struggled with supplies of a competing COPD drug.
In February, the U.K.-based company informed local authorities it intended to build a $137 million, four-story facility at its site in Scotland for the production of salbutamol, the API in Ventolin.