AirDuo Digihaler 113/14 Inhalation Powder Subpotent Drug Recall
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.
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. The source text does not report any illnesses, hospitalizations, or injuries from the subpotent dose. The hazard is a product defect (lower-than-labeled drug content) rather than contamination, and no clinical harm is documented.
Plain-English summary
Teva Pharmaceuticals USA is recalling AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder due to subpotent drug results. Testing found that out-of-specification (OOS) results for the label-claimed emitted dose of salmeterol, meaning some units delivered less of this active ingredient than stated on the label.
The recalled product is a prescription-only inhalation powder manufactured in Ireland and marketed by Teva Respiratory, LLC of Frazer, PA. The recall involves 10,665 sample inhalers with lot code AFR17A that were distributed nationwide.
Consumers and healthcare providers who have this product should contact Teva Pharmaceuticals for instructions on how to proceed. Patients should not abruptly stop using their asthma medication without consulting a healthcare provider.
The recalled product
- Product
- AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Inhalation Powder
- Hazard
- Affected units
- 10,665
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)
- AFR17A
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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