Prescription respiratory drug recalled for short fill in unit-dose vials
Cipla USA recalls Ipratropium Bromide and Albuterol Sulfate inhalation solution due to short fill in unit-dose vials. Some vials contain less medication than labeled, affecting dosage.
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: The source reports no illnesses or injuries, making this a theoretical risk-of-harm scenario involving inadequate medication volume in a prescription respiratory drug. Per the rubric, 'risk-of-harm products where injury has not yet been reported' score 3 (High).
Plain-English summary
Cipla USA, Inc. is recalling Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, a prescription inhalation medication, due to a manufacturing defect. The product was distributed nationwide in the United States.
The company identified short fill as the issue—some vials contain less liquid fill volume than specified, with liquid observed in intact pouches. This affects the amount of medication available in the affected unit-dose vials.
The recall covers vials from lot numbers IA30390 (expiration date 4/30/2025) and IA30517 (expiration date 6/30/2025). Patients currently using affected lots should contact their healthcare provider or pharmacist.
Do not stop using the medication without medical guidance. Patients should consult their healthcare provider about their options and contact Cipla USA, Inc. with questions. The manufacturer's contact information is available on the medication package.
The recalled product
- Product
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
- Brand
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Inhalation Solution
- Hazard
- short-fill
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 # IA30390
- Exp 4/30/2025
- IA30517
- Exp 6/30/ 2025
Distribution
Distributed nationwide across the United States.
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