D-0004-2015 Class II Terminated
FDA drug recall D-0004-2015 was initiated by Baxter Healthcare Corp. on Sep 29, 2014 and is designated Class II. 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. The recall status is terminated (terminated Sep 30, 2016). Affected quantity: 11,808 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 8, 2014
- Initiation Date
- Sep 29, 2014
- Termination Date
- Sep 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,808 bags
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.
Distribution Pattern
Nationwide and Canada
Code Information
Lot# P303172; Exp. 12/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0004-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026