D-1550-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 12, 2022
- Initiation Date
- September 29, 2022
- Termination Date
- July 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9041 cartons
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: environmental monitoring failure.
Distribution Pattern
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
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