Home / Recalls / South Coast Specialty Compounding, Inc. / D-1415-2015

D-1415-2015 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
September 9, 2015
Initiation Date
April 23, 2015
Termination Date
May 31, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 suppositories (24 prescriptions)

Product Description

Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA

Reason for Recall

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Distribution Pattern

Nationwide.

Code Information

Lot #: 01052015@12 01132015@2 01132015@36 01132015@37 01152015@4 01162015@66 01202015@34 02112015@11 02112015@11 02252015@34 10312014@13 11042014@42 11052014@46 11072014@21 11122014@43 11122014@45 11182014@15 11192014@41 11242014@29 11262014@14 12022014@13 12102014@4 12192014@40 12222014@18 Exp. 07/15

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-1338-2015 Class II — Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, I (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-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)