FDA Drug recall D-0471-2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials…
- FDA Drug
- Class II
- terminated
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials… by Cipla Usa, citing short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0471-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-03-26 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla Usa |
| Distribution | US |
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
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Identifiers
| ndc | 69097-173-64 |
|---|---|
| ndc | 69097-173-53 |
| code_info | Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0471-2024%22
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