Status
Terminated
Drug Enforcement D-1545-2022
Lack of Assurance of Sterility
1 Views
Classification
Class II
Report Date
October 5, 2022
Termination Date
January 10, 2024
Product Information
- 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.
- Product quantity
- 641,160 ampules
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Location & Firm
- Recalling firm
- CIPLA
- Address
-
10 Independence Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1545-2022
- Event ID
- 90864
- Recall initiation date
- September 15, 2022
- Center classification date
- September 27, 2022
- Code info
- Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024
- More code info
- —