Home / Recalls / AVKARE Inc. / D-0055-2018

D-0055-2018 Class II Terminated

Recalled by AVKARE Inc. — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
November 8, 2017
Initiation Date
October 6, 2017
Termination Date
March 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
274 cartons

Product Description

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 18103 Exp. 11/18

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