Drug product
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
D-0004-2015
Product summary
- Event
- Event 69303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,808 bags
- Official record key
drug-enforcement:D-0004-2015
Official wording
Reason: 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.
Code information: Lot# P303172; Exp. 12/14
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility