Food, drugs, devices › GlaxoSmithKline, LLC.

Drug recall: Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Or

FDA enforcement event 63707 · Class III · initiated 24 Oct 2012 · status Terminated · terminated 11 Sep 2014

DrugVoluntary: Firm initiated2 product recordsZebulon, NC

GlaxoSmithKline, LLC. (Zebulon, NC) initiated this drug recall on 24 Oct 2012; FDA lists 2 product records under event 63707, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 28% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 11 Sep 2014. Initiation: voluntary: firm initiated. GlaxoSmithKline, LLC. has 13 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

GlaxoSmithKline, LLC., Zebulon, NC.

Reason for recall

"Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification."

Distribution

"Nationwide and Puerto Rico."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-064-2013	Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.	310,964 Aerosol Units	Class III	Terminated	5 Dec 2012
D-065-2013	Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.	18,676 Aerosol Units	Class III	Terminated	5 Dec 2012

Context

28%of 2012 drug events are Class III209 events that year

2product records in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for GlaxoSmithKline, LLC.

Initiated	Product (first record)	Type	Class	Records
17 May 2024	Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table	Drug	Class III	1
12 Dec 2023	ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters t	Drug	Class III	1
13 May 2022	Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497	Drug	Class III	1
16 May 2017	Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx on	Drug	Class II	1
22 Mar 2017	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhaler	Drug	Class II	1
18 Jul 2016	Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709,	Drug	Class II	4
3 Dec 2015	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral I	Drug	Class II	1
13 Aug 2015	Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road	Drug	Class II	4
6 Nov 2013	Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containin	Drug	Class II	2
17 Oct 2013	Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened w	Device	Class II	1

All 13 events for GlaxoSmithKline, LLC.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide and Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 Sep 2014. "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.