FDA recall D-1341-2015

South Coast Specialty Compounding, Inc. · Class II · drug

Product

Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2015-04-23
Report date: 2015-09-09
Termination date: 2016-05-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1341-2015