Specialty Medicine Compounding Pharmacy

FDA Regulatory Profile

Summary

Total Recalls
51
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-412-2014Class IIBevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding PharOctober 19, 2013
D-414-2014Class IICombo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciproflOctober 19, 2013
D-455-2014Class IIVIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine CoOctober 19, 2013
D-432-2014Class IIMultitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydraOctober 19, 2013
D-431-2014Class IIMETHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN*October 19, 2013
D-423-2014Class IIGlutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LafayetOctober 19, 2013
D-440-2014Class IIPolidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, SouthOctober 19, 2013
D-442-2014Class IIProparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350October 19, 2013
D-428-2014Class IILIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding PharOctober 19, 2013
D-417-2014Class IIDEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding PharmacyOctober 19, 2013
D-446-2014Class IISodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LafaOctober 19, 2013
D-426-2014Class IIHYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S October 19, 2013
D-453-2014Class IITRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverinOctober 19, 2013
D-450-2014Class IITESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding PharmacOctober 19, 2013
D-443-2014Class IIQUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUOctober 19, 2013
D-430-2014Class IIMETHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 SOctober 19, 2013
D-435-2014Class IINeomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine CompoundingOctober 19, 2013
D-424-2014Class IIGLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LaOctober 19, 2013
D-452-2014Class IITROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LafayetOctober 19, 2013
D-459-2014Class IIDT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100October 19, 2013