Perrigo said that the company stopped production and distribution of its albuterol sulfate metered dose inhalers in the US and has issued a recall of the MDIs “out of an abundance of caution as a result of complaints that some units may not dispense due to clogging.” The company noted that the inhalers are manufactured by Catalent Pharma Solutions and said that there have been no sales of the product since August 2020.
According to Perrigo, “Corrective action plans are underway and a definitive timeline for product reintroduction has not been determined at this time.” In a discussion of the financial impact of the recall, the company estimated that it would take a $18-22 million charge against earnings in the third quarter and said that its reaffirmation of previous earnings guidance assumes that it will have no further sales of the albuterol MDIs this year.
The FDA approved Perrigo’s ANDA for its version of Teva’s ProAir HFA in February 2020. The ANDA was filed initially in 2012, and Teva immediately filed suit against Perrigo and Catalent for patent infringement at that time. In 2014, a settlement provided for Perrigo to market its generic ProAir in unlimited quantities beginning in July 2018, but the FDA issued a complete response letter to the ANDA in May 2018.
Read the Perrigo press release.
