Drug 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.
D-1545-2022
Product summary
- Firm
- CIPLA
- Event
- Event 90864
- Status
- Terminated
- Classification
- Class II
- Quantity
- 641,160 ampules
- Official record key
drug-enforcement:D-1545-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility