GlaxoSmithKline, LLC

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
0
Inspections
27
Compliance Actions
0

Known Names

glaxosmithkline, glaxosmithkline manufacturing, glaxosmithkline vaccines, glaxosmithkline research and development limited, glaxosmithkline gmbh and co. kg, glaxosmithkline worthing, 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-1443-2016Class IIBactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research TriaJuly 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-0519-2016Class IIVentolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations,December 3, 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-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-1360-2015Class IIBactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK LtAugust 13, 2015
D-387-2014Class IIImitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartrNovember 6, 2013
D-388-2014Class IISumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-DosNovember 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-064-2013Class IIIAdvair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 MetereOctober 24, 2012
D-065-2013Class IIIAdvair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST,October 24, 2012