D-1410-2015 Class II Terminated

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

FDA drug recall D-1410-2015 was initiated by South Coast Specialty Compounding, Inc. on April 23, 2015 and is designated Class II. Reason for recall: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. The recall status is terminated (terminated May 31, 2016). Affected quantity: 5 prescriptions.

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
5 prescriptions

Product Description

Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, 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 # 01152015@20,03032015@22, 03032015@22, 03092015@55,12052014@20; Exp 07/15