Inhalation Drug Recalled Due to Sterility Assurance Failure
Cipla recalls Budesonide Inhalation Suspension ampules due to inability to assure sterility. Affected lots GA20080, GA20081, and GA20094 expire January 2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with lack of sterility assurance for an inhalation drug. While no illnesses or injuries have been reported, non-sterile inhalation medications pose serious risk of infection to the lungs.
Plain-English summary
Cipla USA Inc. is recalling Budesonide Inhalation Suspension 0.25mg/2mL (Lot numbers GA20080, GA20081, GA20094; expiration January 2024), a prescription respiratory medication supplied as single-dose ampules. The company distributed 641,160 ampules nationwide.
The recall was issued because the manufacturer cannot assure that all units in these lots meet the required sterility standards for inhalation products. Budesonide inhalation suspension is administered directly to the lungs, where sterility is a critical safety requirement.
The affected product was distributed nationwide in the United States and Puerto Rico. Patients who have received medication from these lots should consult their healthcare provider.
Patients should not use affected units and should contact their healthcare provider for a replacement or alternative medication. Report any adverse effects to the FDA or the manufacturer.
The recalled product
- Product
- BUDESONIDE (BUDESONIDE)
- Brand
- BUDESONIDE
- Manufacturer
- CIPLA
- Category
- Drug — Inhalation Suspension
- Affected units
- 641,160
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 (4)
- Lot #s: GA20080
- GA20081
- GA20094
- Exp. 01/2024
Distribution
Related recalls
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Similar recalls
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