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Specialty Medicine Compounding Pharmacy

Complete recall history across all FDA and CPSC categories — 51 total recalls

Specialty Medicine Compounding Pharmacy 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 (51)

FDA drug safety enforcement actions by Specialty Medicine Compounding Pharmacy. Showing most recent 50.

Date Product Reason Class
Oct 19, 2013 FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compou... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medici... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compoundi... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Comp... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL IN... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy,... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH ... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Co... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Com... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medic... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Med... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty M... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compo... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Me... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty M... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/m... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Med... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compoundi... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cu... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compou... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medici... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medic... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compoundin... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/m... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medici... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compoun... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medic... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJEC... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compo... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Special... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compoun... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 m... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx o... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Comp... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Ph... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tr... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding ... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Me... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding ... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding P... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Comp... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II
Oct 19, 2013 Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofen... Lack of Assurance of Sterility: All unexpired sterile compounded human and ve... Class II

View all 51 drug recalls →

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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