FDAClass IIOctober 27, 2021

AirDuo Digihaler 55/14 recall: Subpotent

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA…

Why was AirDuo Digihaler 55/14 recalled?

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

AFR16A

Product
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA…
Recalling firm
Teva Pharmaceuticals USA
Quantity
1,978 inhalers
Distribution
USA Nationwide
Recall date
October 27, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls