Recalls / Class II
Class IID-0004-2015
Product
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
- Brand name
- Dopamine Hydrochloride And Dextrose
- Generic name
- Dopamine Hydrochloride
- Active ingredient
- Dopamine Hydrochloride
- Route
- Intravenous
- NDCs
- 0338-1005, 0338-1007, 0338-1009
- FDA application
- NDA019615
- Affected lot / code info
- Lot# P303172; Exp. 12/14
Why it was 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.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 11,808 bags
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2014-09-29
- FDA classified
- 2014-10-02
- Posted by FDA
- 2014-10-08
- Terminated
- 2016-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0004-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.