GlaxoSmithKline recalls
FDA enforcement reports naming GlaxoSmithKline Inc as the recalling firm.
- Recall reports
- 22
- Class I (serious)
- 0
- Most recent report
- Jun 12, 2024
- Jun 12, 2024Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carto…Drug · GlaxoSmithKline LLCLabeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.Class III
- Jan 3, 2024ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62Drug · GlaxoSmithKline LLCFailed Release Testing: Coarse Particle Mass for umeclidinium Out of SpecificationClass III
- Jun 1, 2022Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV…Drug · GlaxoSmithKline LLCLabeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.Class III
- May 31, 2017Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered InhalationsDrug · GlaxoSmithKline, LLCDefective Delivery System: Elevated number of units with out of specification results for leak rateClass II
- Apr 12, 2017Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered…Drug · GlaxoSmithKline, LLCDefective Delivery System: Elevated number of units with out of specification results for leak rate.Class II
- Jul 27, 2016Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, Gla…Drug · GlaxoSmithKline, LLCPenicillin Cross ContaminationClass II
- Jul 27, 2016Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline,…Drug · GlaxoSmithKline, LLCPenicillin Cross ContaminationClass II
- Jul 27, 2016Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, R…Drug · GlaxoSmithKline, LLCPenicillin Cross ContaminationClass II
- Jul 27, 2016Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline,…Drug · GlaxoSmithKline, LLCPenicillin Cross ContaminationClass II
- Dec 16, 2015Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered…Drug · GlaxoSmithKline, LLCDefective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.Class II
- Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (…
- Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glax…
- Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-…
- Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Ope…
- Sumatriptan Succinate Injection, 6 mg, 0
- Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0
- TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Ta…
- Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I
- Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12…
- Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Act…
- Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered I…
- Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets,…
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