FDA-Drug2014-10-08Class II

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

Baxter Healthcare Corp.
Hazard

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.

Sold states
Nationwide and Canada
Affected count
11,808 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2015

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