AirDuo Digihaler 55/14 Inhalation Powder Recalled for Subpotent Dose
Teva Pharmaceuticals is recalling AirDuo Digihaler 55/14 inhalation powder due to subpotent emitted dose of salmeterol. Approximately 1,978 inhalers distributed nationwide may deliver less medication than labeled.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a maintenance asthma medication with a potency defect that could compromise therapeutic efficacy. Although no hospitalizations or adverse events are reported in the source text, the subpotent dose of salmeterol in a critical respiratory maintenance therapy meets the Class II severe criterion.
Plain-English summary
Teva Pharmaceuticals USA is recalling AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, NDC 59310-111-06, lot AFR16A, manufactured in Ireland. The recall was initiated because out-of-specification (OOS) test results showed that the emitted dose of salmeterol did not meet the labeled claimed amount.
Approximately 1,978 inhalers were distributed nationwide. Patients using affected inhalers may receive less salmeterol than the labeled dose, which could reduce the medication's intended therapeutic effect.
Patients currently using this product should not stop taking their medication without consulting their healthcare provider. Those with questions or who believe they may have received an affected inhaler should contact their physician or pharmacist for guidance on obtaining a replacement or alternative asthma maintenance treatment.
The recalled product
- Product
- AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 1,978
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)
- AFR16A
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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