Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Recall initiated: 20171006
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated