DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.

Recall Number: D-0004-2015

Firm: Baxter Healthcare Corp.

Classification: Class II

Status: Terminated

Report Date: 20141008

Initiation Date: 20140929

Termination Date: 20160930

Reason for Recall

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Product Description

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.