FDA recall D-142-2013

Product

Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

Reason for recall

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2012-12-21

Report date

2013-02-06

Termination date

2015-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fajardo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-142-2013