Home / Recalls / South Coast Specialty Compounding, Inc. / D-1027-2013

D-1027-2013 Class II Terminated

Recalled by South Coast Specialty Compounding, Inc. — Irvine, CA

Recall Details

Product Type
Drugs
Report Date
September 18, 2013
Initiation Date
August 23, 2013
Termination Date
October 17, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
117 vials

Product Description

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

Reason for Recall

Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.

Distribution Pattern

CA, IN

Code Information

Lot #05072013@1, Exp 11/3/2013

Other recalls by South Coast Specialty Compounding, Inc.

  • D-1409-2015 Class II — Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, (April 23, 2015)
  • D-1407-2015 Class II — Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsul (April 23, 2015)
  • D-1342-2015 Class II — Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufac (April 23, 2015)
  • D-1415-2015 Class II — Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactu (April 23, 2015)
  • D-1411-2015 Class II — Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA (April 23, 2015)
  • D-1410-2015 Class II — Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Man (April 23, 2015)
  • D-1414-2015 Class II — Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactu (April 23, 2015)
  • D-1339-2015 Class II — Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA (April 23, 2015)
  • D-1412-2015 Class II — Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Com (April 23, 2015)
  • D-1341-2015 Class II — Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 U (April 23, 2015)