RecallDepth
Class II Terminated

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

Company
Teva Pharmaceuticals Usa
Recall Initiated
September 22, 2021
Posted
October 27, 2021
Recall Number
D-0023-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
1,978 inhalers
Firm Location
Parsippany, NJ, United States

Reason for Recall

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

Distribution

USA Nationwide

Lot / Code Info

AFR16A

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