Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Lab...
FDA Recall #D-0181-2016 — Class III — October 21, 2015
Product Description
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
Recalling Firm
Breckenridge Pharmaceutical, Inc — Berlin, CT
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
595 Bottles
Distribution
Nationwide
Code Information
Lot #: 142391, Exp 10/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated