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.
What this means for you
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
- Hazard
- subpotent-drug
- out-of-specification
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.
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