DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Reported: October 8, 2014 Initiated: September 29, 2014 #D-0004-2015
Product Description
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.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 11,808 bags
- Distribution
- Nationwide and Canada
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.. Recalled by Baxter Healthcare Corp.. Units affected: 11,808 bags.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 8, 2014. Severity: Moderate. Recall number: D-0004-2015.
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