Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve,…

Recall date

October 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0181-2016

FDA classification

Class III

Brand / firm

Breckenridge Pharmaceutical, Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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