Recalls / Class II
Class IID-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.
- Brand name
- Budesonide
- Generic name
- Budesonide
- Active ingredient
- Budesonide
- Route
- Oral
- NDCs
- 69097-318, 69097-319, 69097-321
- FDA application
- ANDA205710
- Affected lot / code info
- Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- CIPLA
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 641,160 ampules
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-09-15
- FDA classified
- 2022-09-27
- Posted by FDA
- 2022-10-05
- Terminated
- 2024-01-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1545-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.