Drug recall D-1545-2022
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 for recall
Lack of Assurance of Sterility
Lots and codes
Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Recall details
- Recalling firm
- CIPLA, Warren, NJ
- Quantity
- 641,160 ampules
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 15, 2022
- Terminated
- January 10, 2024
Related products
- Budesonide – drug information
- NDC 69097-319 Budesonide Inhalation Suspension · Budesonide .5 mg/2mL · Cipla USA Inc.
- NDC 69097-321 Budesonide Inhalation Suspension · Budesonide 1 mg/2mL · Cipla USA Inc.
- NDC 69097-318 Budesonide Inhalation Suspension · Budesonide .25 mg/2mL · Cipla USA Inc.