DOPamine Hydrochloride and 5% Dextrose INJ recall: Sterility Concern
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Why was DOPamine Hydrochloride and 5% Dextrose INJ 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# P303172; Exp. 12/14
- Product
- DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 11,808 bags
- Distribution
- Nationwide and Canada
- Recall date
- October 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)