Warning
Breckenridge Pharmaceutical Recalls Duloxetine Delayed-Release Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0216-2026Drug / Pharmaceutical
Breckenridge Pharmaceutical Recalls Duloxetine Delayed-Release Capsules
Breckenridge Pharmaceutical, Inc. · Class II — Moderate Risk
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database