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.

Recall Number: D-0055-2018

Firm: AVKARE Inc.

Classification: Class II

Status: Terminated

Report Date: 20171108

Initiation Date: 20171006

Termination Date: 20190311

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

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.