FDA Drug recall D-1545-2022
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Su…
- FDA Drug
- Class II
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Su… by Cipla, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1545-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-15 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla |
| Distribution | US |
Product
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 for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Reason
Lack of Assurance of Sterility
Identifiers
| ndc | 69097-318-86 |
|---|---|
| ndc | 69097-318-87 |
| ndc | 69097-318-32 |
| ndc | 69097-318-53 |
| ndc | 69097-319-86 |
| ndc | 69097-319-87 |
| ndc | 69097-319-32 |
| ndc | 69097-319-53 |
| ndc | 69097-321-86 |
| ndc | 69097-321-87 |
| ndc | 69097-321-32 |
| ndc | 69097-321-53 |
| code_info | Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024 |
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-1545-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.