Actelion Recalls Three Cartons of Subpotent Ventavis Inhalation Solution
Actelion Pharmaceuticals is recalling three cartons of Ventavis (iloprost) Inhalation Solution due to an out-of-specification assay result indicating the drug was subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. A score of 2 is assigned because the product is subpotent (a functional defect) rather than a cosmetic or packaging-only issue, representing a low-risk contamination or quality deviation.
Plain-English summary
Actelion Pharmaceuticals U.S., Inc. is recalling three cartons of Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, sterile, 30 single-use ampules per carton. The specific lot number is MA00AD5 with an expiration date of 11/30/2014. The product was distributed in California and Virginia.
The recall was initiated because the drug failed to meet specifications during stability testing at the 12-month time point, resulting in an out-of-specification (OOS) assay result. This indicates the medication was subpotent, meaning it contained less of the active ingredient than required.
Patients who have received this specific lot of Ventavis should contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.
- Manufacturer
- Actelion Pharmaceuticals U.S., Inc.
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 3
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)
- Lot #: MA00AD5
- Exp: 11/30/2014
Distribution
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