Drug recall
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose…
FDA recall event 90864 · Class II · CIPLA
Key facts
| Event ID | 90864 |
|---|---|
| Recall numbers | D-1545-2022 |
| Recalling firm | CIPLA |
| Product type | Drugs |
| Products | Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility |
| Initiation date | Sep 15, 2022 |
| Report date | Oct 5, 2022 |
| Termination date | Jan 10, 2024 |
| City | Warren |
| State | NJ |
| Country | United States |
| FEI number | 3014780658 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: