Orlando, Florida-based Nephron Pharmaceuticals Corp (NPC) has initiated a voluntary recall at the retail level of 10 lots of albuterol sulfate inhalation solution, 0.083%.
The recall is a "precautionary measure" stemming from internal monitoring processes, the company says in a press release.
The recall affects albuterol sulfate inhalation solution, 0.083%, in the 25-count packaging configuration with national drug code (NDC) 0487-9501-25.
The 10 affected lots are: A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.
The company is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. NPC customers include retail pharmacies, hospitals, home-care companies, long-term-care facilities, and mail-order pharmacies.
"The product was distributed in the US and Puerto Rico. Nephron Pharmaceuticals has contacted wholesalers by email and letter, and retailers are responsible for contacting consumers to discontinue use and dispose of any products they may have affected by the recall," NPC recall coordinator Dessiree Fermin told Medscape Medical News by email.
"NPC performs aseptic process simulation as part of our internal processes to assure product quality. All of the recalled lots met and passed NPC's quality specifications at the time of manufacture," the company reports.
"NPC has received no reportable adverse drug events for any of the lots included in this recall. Nevertheless, in accordance with published guidance regarding aseptic processing simulation from the Food and Drug Administration (FDA), NPC has decided to initiate this recall as a precautionary measure," the company says.
No other NPC products or lots are impacted by this recall.