GlaxoSmithKline, LLC.

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
0
Inspections
26
Compliance Actions
0

Known Names

glaxosmithkline, glaxosmithkline manufacturing, glaxosmithkline vaccines, glaxosmithkline research and development limited, glaxosmithkline gmbh and co. kg, glaxosmithkline gmbh and co.kg, glaxosmithkline consumer healthcare gmbh and co. kg, glaxosmith-kline

Recent Recalls

NumberClassProductDate
D-0544-2024Class IIITivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains onMay 17, 2024
D-0160-2024Class IIIANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30December 12, 2023
D-0896-2022Class IIITivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTMay 13, 2022
D-0793-2017Class IIVentolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. May 16, 2017
D-0626-2017Class IIVentolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, March 22, 2017
D-1442-2016Class IIBactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research TriJuly 18, 2016
D-1445-2016Class IIBactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research TrianJuly 18, 2016
D-1444-2016Class IIBactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline,July 18, 2016
D-1443-2016Class IIBactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research TriaJuly 18, 2016
D-0519-2016Class IIVentolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations,December 3, 2015
D-1360-2015Class IIBactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK LtAugust 13, 2015
D-1362-2015Class IIMupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only,August 13, 2015
D-1361-2015Class IIBactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527August 13, 2015
D-1359-2015Class IIBactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations August 13, 2015
D-388-2014Class IISumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-DosNovember 6, 2013
D-387-2014Class IIImitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartrNovember 6, 2013
Z-0272-2014Class IIBiotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., SuOctober 17, 2013
D-850-2013Class IIITUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSJuly 18, 2013
D-065-2013Class IIIAdvair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST,October 24, 2012
D-064-2013Class IIIAdvair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 MetereOctober 24, 2012