D-1545-2022 Class II Terminated
FDA drug recall D-1545-2022 was initiated by CIPLA on Sep 15, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jan 10, 2024). Affected quantity: 641,160 ampules.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 5, 2022
- Initiation Date
- Sep 15, 2022
- Termination Date
- Jan 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 641,160 ampules
Product Description
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 for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1545-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026