Specialty Medicine Compounding Pharmacy

FDA Drug Class II Terminated

Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 8090.8 mL units

FDA Drug Class II Terminated

TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 3000 mL units

FDA Drug Class II Terminated

Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 20 mL units

FDA Drug Class II Terminated

Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 126 mL units

FDA Drug Class II Terminated

Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 2801 doses units

FDA Drug Class II Terminated

TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5.5 mL units

FDA Drug Class II Terminated

DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, Sou

October 19, 2013 Specialty Medicine Compounding Pharmacy a) Injectable 600 mL; b) Topical 800 mL units

FDA Drug Class II Terminated

TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 33 mL units

FDA Drug Class II Terminated

NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 100 mL units

FDA Drug Class II Terminated

METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 20 mL units

FDA Drug Class II Terminated

Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 1351 mL units

FDA Drug Class II Terminated

QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER

October 19, 2013 Specialty Medicine Compounding Pharmacy 86 mL units

FDA Drug Class II Terminated

GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 210 mL units

FDA Drug Class II Terminated

Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5582.6 mL units

FDA Drug Class II Terminated

HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 70 mL units

FDA Drug Class II Terminated

Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 11 mL units

FDA Drug Class II Terminated

METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTAB

October 19, 2013 Specialty Medicine Compounding Pharmacy 726.45 mL units

FDA Drug Class II Terminated

Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 100 mL units

FDA Drug Class II Terminated

TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 17.5 ml units

FDA Drug Class II Terminated

EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 30 mL units

FDA Drug Class II Terminated

Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 44.44 mL units

FDA Drug Class II Terminated

Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 180 mL units

FDA Drug Class II Terminated

TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350

October 19, 2013 Specialty Medicine Compounding Pharmacy 44 mL units

FDA Drug Class II Terminated

FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 4.4 mL units

FDA Drug Class II Terminated

POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 600 mL units

FDA Drug Class II Terminated

DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 70 mL units

FDA Drug Class II Terminated

Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 160 grams units

FDA Drug Class II Terminated

Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medici

October 19, 2013 Specialty Medicine Compounding Pharmacy 186 mL units

FDA Drug Class II Terminated

Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 180 mL units

FDA Drug Class II Terminated

VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 204 doses units

FDA Drug Class II Terminated

Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 35.5 mL units

FDA Drug Class II Terminated

SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 9200 mL units

FDA Drug Class II Terminated

Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 6 mL units

FDA Drug Class II Terminated

LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 65 mL units

FDA Drug Class II Terminated

SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 10 mL units

FDA Drug Class II Terminated

QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 15 mL units

FDA Drug Class II Terminated

HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 53 mL units

FDA Drug Class II Terminated

HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 420 mL units

FDA Drug Class II Terminated

CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5 mL units

FDA Drug Class II Terminated

NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 120 mL units

FDA Drug Class II Terminated

Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 6 mL units

FDA Drug Class II Terminated

EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 157.08 mL units

FDA Drug Class II Terminated

Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 10 mL units

FDA Drug Class II Terminated

WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy a) 1900 injectable; b) 1900 mL topical units

FDA Drug Class II Terminated

VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 50 mL units

FDA Drug Class II Terminated

Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 148.075 ml units

FDA Drug Class II Terminated

Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 38 doses units

FDA Drug Class II Terminated

Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 19200 mL units

FDA Drug Class II Terminated

FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 700 mL units

FDA Drug Class II Terminated

0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 35

October 19, 2013 Specialty Medicine Compounding Pharmacy a) Injectable 800 mL; b) Topical 600 mL units