AirDuo Digihaler 232/14 Inhalation Powder Recall for Subpotent Salmeterol
Teva Pharmaceuticals is recalling approximately 5,500 units of AirDuo Digihaler 232/14 inhalation powder distributed nationwide because some inhalers contain less salmeterol than the labeled dose.
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 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: This is an FDA Class II recall involving a subpotent drug with out-of-specification results. The source text does not report any hospitalizations, illnesses, or injuries, and the hazard is the risk of underdosing rather than contamination or acute harm. Class II recalls without reported adverse events typically warrant a Moderate severity score.
Plain-English summary
Teva Pharmaceuticals USA is recalling AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder with code AFR18A. The recall was initiated because out-of-specification test results showed that some inhalers emitted less salmeterol than the label claimed.
Approximately 5,500 inhalers were distributed nationwide. The product is a prescription-only asthma and COPD medication manufactured in Ireland by Teva Respiratory, LLC (Frazer, PA).
Patients currently using affected inhalers should contact their healthcare provider or pharmacist immediately. Do not abruptly stop using the medication without medical guidance, as this could worsen respiratory symptoms. Consult a healthcare professional about whether your supply is affected and what steps to take next.
The recalled product
- Product
- AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Respiratory / Asthma-COPD
- Hazard
- Affected units
- 5,500
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 (1)
- AFR18A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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