FDA recall D-1348-2015

Ucb, Inc · Class II · drug

Product

univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.

Reason for recall

Failed Dissolution Testing: Failed 24 month dissolution testing.

Distribution

U.S. Nationwide

Key facts

Status: Terminated
Initiation date: 2015-07-24
Report date: 2015-08-26
Termination date: 2017-07-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Smyrna, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1348-2015