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.
Reported: October 5, 2022 Initiated: September 15, 2022 #D-1545-2022
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
Details
- Recalling Firm
- CIPLA
- Units Affected
- 641,160 ampules
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CIPLA. Units affected: 641,160 ampules.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2022. Severity: Moderate. Recall number: D-1545-2022.
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