South Coast Specialty Compounding, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1409-2015Class IIEstradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CAApril 23, 2015
D-1338-2015Class IILeucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CAApril 23, 2015
D-1407-2015Class IITri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, ManufactApril 23, 2015
D-1342-2015Class IIMethyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park CompouApril 23, 2015
D-1415-2015Class IIBi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park CompoundApril 23, 2015
D-1411-2015Class IIEstriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CAApril 23, 2015
D-1410-2015Class IIBi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park CoApril 23, 2015
D-1414-2015Class IIBi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park CompoundApril 23, 2015
D-1339-2015Class IIMeloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formuApril 23, 2015
D-1412-2015Class IIBi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CAApril 23, 2015
D-1341-2015Class IIChorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vApril 23, 2015
D-1413-2015Class IIEstradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CAApril 23, 2015
D-1340-2015Class IIArtesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park CompoundiApril 23, 2015
D-1408-2015Class IIEstradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CAApril 23, 2015
D-1337-2015Class IIBi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by ParkApril 23, 2015
D-1026-2013Class IIMultitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose ViaAugust 23, 2013
D-1025-2013Class IIMethylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, PaAugust 23, 2013
D-1027-2013Class IITestosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, IrAugust 23, 2013