Status
Terminated
Drug Enforcement D-1550-2022
Lack of Assurance of Sterility: environmental monitoring failure.
1 Views
Classification
Class II
Report Date
October 12, 2022
Termination Date
July 25, 2023
Product Information
- 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.
- Product quantity
- 9041 cartons
- Reason for recall
- Lack of Assurance of Sterility: environmental monitoring failure.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Location & Firm
- Recalling firm
- CIPLA
- Address
-
10 Independence Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1550-2022
- Event ID
- 90920
- Recall initiation date
- September 29, 2022
- Center classification date
- September 30, 2022
- 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
- More code info
- —