Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP — Class II drug recall D-0471-2024
Terminated recall by Cipla USA, Inc., reported 2024-05-01, distributed nationwide. Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact
| Recall number | D-0471-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2024-03-26 |
| Classified | 2024-04-24 |
| Reported by FDA | 2024-05-01 |
| Terminated | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 59,244 |
| NDC | 69097-0173, 69097-0173-53, 69097-0173-64 |
| Lot numbers | 2025, 6/30, IA30390, IA30517 |
| Expiration dates | 2025-04-30 |
Product
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Reason for recall
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
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-0471-2024. 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.