CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dos
Recalled October 12, 2022 · FDA recall D-1550-2022 · CIPLA
Hazard
Lack of Assurance of Sterility: environmental monitoring failure. · FDA Class II
Units
9041 cartons
Sold at
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Description
Lack of Assurance of Sterility: environmental monitoring failure.
Product
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
Manufacturer(s)
CIPLA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →