FDA recall D-0181-2016

Product

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10

Reason for recall

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-21

Report date

2015-11-18

Termination date

2015-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0181-2016