Cipla USA Recalls Budesonide Inhalation Suspension for Lack of Sterility Assurance
Cipla USA is recalling Budesonide Inhalation Suspension due to lack of sterility assurance following market complaints of leakage and empty ampoules.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving sterility assurance failure in a drug product. No illnesses or injuries have been reported. The hazard represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Cipla USA, Inc. is recalling Budesonide Inhalation Suspension, 0.5 mg/2 mL, NDC 69097-319-86 (pouch) and 69097-319-87 (carton), distributed nationwide. The recall affects approximately 13,680 ampoules from batch 4IA0505.
The recall was initiated due to lack of assurance of sterility following market complaints of leakage from ampoules and reports of empty ampoules. Compromised sterility in an inhalation suspension can pose a risk of infection when the product is inhaled, particularly for patients using this corticosteroid medication to manage respiratory conditions.
Patients currently using Budesonide Inhalation Suspension from the affected batch should contact their healthcare provider immediately for guidance. Do not use the product if the ampoule shows signs of damage, leakage, or appears empty. Healthcare providers and patients should report any adverse events or quality concerns to the FDA's MedWatch program or contact Cipla USA for further information.
The recalled product
- Product
- BUDESONIDE (BUDESONIDE)
- Brand
- BUDESONIDE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug
- Hazard
- lack-of-sterility
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 4IA0505
- Exp 09/31/2026
Distribution
Distributed nationwide across the United States.
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