GlaxoSmithKline, LLC.

Complete recall history across all FDA and CPSC categories — 11 total recalls

GlaxoSmithKline, LLC. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (10)

FDA drug safety enforcement actions by GlaxoSmithKline, LLC.

Date Product Reason Class
Aug 13, 2015 Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactur... Penicillin Cross Contamination and Presence of Foreign Substance. Product wa... Class II
Aug 13, 2015 Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC ... Penicillin Cross Contamination and Presence of Foreign Substance. Product wa... Class II
Aug 13, 2015 Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) ... Penicillin Cross Contamination and Presence of Foreign Substance. Product wa... Class II
Aug 13, 2015 Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by... Penicillin Cross Contamination and Presence of Foreign Substance. Product wa... Class II
Nov 6, 2013 Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefill... Lack of Assurance of Sterility: A small number of pre-filled syringes may con... Class II
Nov 6, 2013 Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only... Lack of Assurance of Sterility: A small number of pre-filled syringes may con... Class II
Jul 18, 2013 TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 C... Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Ber... Class III
Oct 24, 2012 Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 m... Product Lacks Stability: These lots are being recalled due to the failure to ... Class III
Oct 24, 2012 Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation A... Product Lacks Stability: These lots are being recalled due to the failure to ... Class III
Oct 8, 2012 Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusio... Impurities/Degradation Products: Potential for drug related impurities to exc... Class II

Device Recalls (1)

FDA medical device enforcement actions by GlaxoSmithKline, LLC.

Date Product Reason Class
Oct 17, 2013 Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief,... Label indicates, "Sweetened with xylitol and Sorbitol", however product does ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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