CIPLA: 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

Hazard

Lack of Assurance of Sterility: environmental monitoring failure.

Details from the source

Reason for recall: Lack of Assurance of Sterility: environmental monitoring failure. Distribution: Product was distributed nationwide to distributors/wholesalers who may have further distributed the product. Quantity: 9041 cartons Lot/code info: Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.