Drug recall D-0004-2015

Class II Terminated reported Oct 8, 2014

Product

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

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.

Lots and codes

Lot# P303172; Exp. 12/14

Recall details

Recalling firm
Baxter Healthcare Corp., Deerfield, IL
Quantity
11,808 bags
Distribution
Nationwide and Canada
Type
Voluntary: Firm initiated
Recall initiated
September 29, 2014
Terminated
September 30, 2016

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