Recalls / Class II
Class IID-1550-2022
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.
- Brand name
- Arformoterol Tartrate
- Generic name
- Arformoterol Tartrate
- Active ingredient
- Arformoterol Tartrate
- Route
- Respiratory (inhalation)
- NDC
- 69097-168
- FDA application
- ANDA207306
- Affected 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
Why it was recalled
Lack of Assurance of Sterility: environmental monitoring failure.
Recalling firm
- Firm
- CIPLA
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 9041 cartons
- Distribution pattern
- Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Timeline
- Recall initiated
- 2022-09-29
- FDA classified
- 2022-09-30
- Posted by FDA
- 2022-10-12
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1550-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.