Food, drugs, devices › Teva Pharmaceuticals USA

Drug recall: AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, R

FDA enforcement event 88738 · Class II · initiated 22 Sep 2021 · status Terminated · terminated 16 Feb 2023

DrugVoluntary: Firm initiated5 product recordsParsippany, NJ

FDA enforcement event 88738 is a drug recall by Teva Pharmaceuticals USA of Parsippany, NJ, initiated 22 Sep 2021 and classified Class II, with 5 product records.

FDA defines Class II as 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. 60% of the 299 drug enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 16 Feb 2023. Initiation: voluntary: firm initiated. Teva Pharmaceuticals USA has 98 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Teva Pharmaceuticals USA, Parsippany, NJ.

Reason for recall

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

Distribution

"USA Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0021-2022	AirDuo Digihaler 113/14 (fluticasone propionate 113 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 59310-520-08	10,665 inhalers	Class II	Terminated	27 Oct 2021
D-0022-2022	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.	3,240 inhalers	Class II	Terminated	27 Oct 2021
D-0023-2022	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	1,978 inhalers	Class II	Terminated	27 Oct 2021
D-0024-2022	AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.	4,850 inhalers	Class II	Terminated	27 Oct 2021
D-0025-2022	AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06	5,500 inhalers	Class II	Terminated	27 Oct 2021

Context

60%of 2021 drug events are Class II299 events that year

5product records in this eventfirm median: 1

98events on this register for the firm

Other enforcement events for Teva Pharmaceuticals USA

Initiated	Product (first record)	Type	Class	Records
18 Jan 2022	Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufa	Drug	Class II	1
10 Jan 2022	Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-08	Drug	Class II	1
7 Jan 2022	Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manuf	Drug	Class III	2
31 Dec 2021	MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactu	Drug	Class II	2
16 Dec 2021	Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (N	Drug	Class II	1
8 Dec 2021	Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper	Drug	Class II	1
28 Oct 2021	Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT I	Drug	Class III	1
27 Oct 2021	Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufac	Drug	Class II	1
29 Jul 2021	Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratori	Drug	Class II	3
29 Jul 2021	DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicine	Drug	Class II	19

All 98 events for Teva Pharmaceuticals USA

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "USA Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Feb 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.