Specialty Medicine Compounding Pharmacy

FDA Regulatory Profile

Specialty Medicine Compounding Pharmacy appears in FDA public data with 51 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-459-2014, Class II) was initiated on October 19, 2013.

Summary

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

Recent Recalls

NumberClassProductDate
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
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-440-2014Class IIPolidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, SouthOctober 19, 2013
D-447-2014Class IIHYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, October 19, 2013
D-421-2014Class IIFLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LafayOctober 19, 2013
D-415-2014Class IICyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding PharmacyOctober 19, 2013
D-420-2014Class IIFLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine CoOctober 19, 2013
D-418-2014Class IIEDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LaOctober 19, 2013
D-425-2014Class IIHyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LafaOctober 19, 2013
D-454-2014Class IIVANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 SOctober 19, 2013
D-438-2014Class IIPhenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South LyoOctober 19, 2013
D-410-2014Class IIAcetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LafayettOctober 19, 2013
D-458-2014Class II0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9October 19, 2013
D-429-2014Class IIMagnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S LOctober 19, 2013
D-422-2014Class IIGatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding PharmacyOctober 19, 2013
D-427-2014Class IIHYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding PharmOctober 19, 2013
D-448-2014Class IIQUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding PhaOctober 19, 2013
D-437-2014Class IIPapaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty MedicineOctober 19, 2013