FDA recall D-1407-2015

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

Product

Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, 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-1407-2015