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The Compounding Shop, Inc.

Complete recall history across all FDA and CPSC categories — 25 total recalls

The Compounding Shop, Inc. appears in recall records across 1 category. 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 (25)

FDA drug safety enforcement actions by The Compounding Shop, Inc.

Date Product Reason Class
May 2, 2013 Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Pap... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded b... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding S... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. P... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, co... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectabl... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The C... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compoundin... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding S... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Pet... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Com... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compo... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by Th... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Sho... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compound... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... Class II
May 2, 2013 Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compoundi... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns ... 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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