AirDuo Digihaler 232/14 Inhalation Powder Subpotent Recall
Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.
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. No illnesses or hospitalizations are reported in the source text, making this a moderate-severity recall consistent with Class II classification without reported patient harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder nationwide. The product is a prescription respiratory inhalation powder manufactured in Ireland and marketed by Teva Respiratory, LLC in Frazer, Pennsylvania (NDC 59310-530-08, batch code AFR18A).
The recall was initiated because out-of-specification (OOS) test results showed that some inhalers did not emit the labeled claimed dose of salmeterol. This means patients using affected units may receive less medication than intended.
A total of 3,240 inhalers are affected by this recall. Healthcare providers and patients currently using this product batch should contact Teva or their healthcare provider for further guidance.
The recalled product
- Product
- AirDuo Digihaler 232/14 (fluticasone propionate 232 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 59310-530-08.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Respiratory / Inhalation
- Affected units
- 3,240
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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