Dopamine Hydrochloride And Dextrose Injection, Solution
FDA Recall NDC 0338-1007
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dopamine Hydrochloride And Dextrose (NDC 0338-1007). A significant event, classified as Class II, was initiated on Sep 29, 2014 by Baxter Healthcare Corporation. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Sep 29, 2014
Oct 08, 2014
11,808 bags
Recall Profile & Regulatory Data
Event ID
69303
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Canada
Termination Date
Sep 30, 2016
Product Description
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Batch or Lot Expiration Information
Lot# P303172; Exp. 12/14
Affected Packages Involved in this Recall
0338-1005-02Product
0338-1005-03Product
0338-1007-02Product
0338-1007-03Product
0338-1009-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
