FDA recall D-1263-2014

Medisca Inc. · Class I · drug

Product

Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3

Reason for recall

Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-10-21
Report date: 2014-05-07
Termination date: 2016-11-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1263-2014