AVKARE Inc. recalls Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 502682…

Recall date

October 6, 2017

Source

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

Recall number

D-0055-2018

FDA classification

Class II

Brand / firm

AVKARE Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.