Class II
Terminated
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.
This recall has been terminated (originally issued October 12, 2022).
- Company
- Cipla
- Recall Initiated
- September 29, 2022
- Posted
- October 12, 2022
- Recall Number
- D-1550-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9041 cartons
- Firm Location
- Warren, NJ, United States
- Official Source
- View on FDA website ↗
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.
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
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