BETHESDA, MD 15 Oct 2013—Nephron Pharmaceuticals Corporation on October 11 announced a recall of 10 lots of the company's 0.083% albuterol sulfate inhalation solution "as a precautionary measure."
The lots are A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.
Nephron said the 10 lots passed the quality specifications at the time of manufacture and no "reportable" adverse drug events for any of those lots have been received.
In the announcement, Nephron said it was undertaking the recall in accordance with FDA's guidance (PDF) regarding simulation of the aseptic processing operation.
Consumers who have albuterol solution from any of the 10 lots are being asked by the company to dispose of the units.