PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 18, 2015 Initiated: October 21, 2015 #D-0181-2016

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

Details

Units Affected
595 Bottles
Distribution
Nationwide
Location
Berlin, CT

Frequently Asked Questions

What product 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. Recalled by Breckenridge Pharmaceutical, Inc. Units affected: 595 Bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Which agency issued this recall?
This recall was issued by the FDA Drug on November 18, 2015. Severity: Low. Recall number: D-0181-2016.