Arformoterol Tartrate Inhalation Solution — Class II drug recall D-1550-2022
Terminated recall by CIPLA, reported 2022-10-12, distributed nationwide. Lack of Assurance of Sterility: environmental monitoring failure.
| Recall number | D-1550-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIPLA, Warren, NJ, United States |
| Recall initiated | 2022-09-29 |
| Classified | 2022-09-30 |
| Reported by FDA | 2022-10-12 |
| Terminated | 2023-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 9,041 cartons |
| Reason classes | sterility |
| NDC | 69097-0168, 69097-0168-32, 69097-0168-48, 69097-0168-53, 69097-0168-64, 69097-0168-87 |
| Lot numbers | IA10082, IA10083, IA10084, IA10085, IA10086, IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130 |
| Expiration dates | 2023-01, 2023-02 |
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.
Reason for recall
Lack of Assurance of Sterility: environmental monitoring failure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1550-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.