Drug 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.
D-1550-2022
Product summary
- Firm
- CIPLA
- Event
- Event 90920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9041 cartons
- Official record key
drug-enforcement:D-1550-2022
Official wording
Reason: Lack of Assurance of Sterility: environmental monitoring failure.
Code information: Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
Distribution pattern: Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility