Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
DOPamine Hydrochloride and 5% Dextrose INJ
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Affected NDC
0338-1005-02
Compare with the code on your package — it is the most precise check available.
Drug: Dopamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride NDC 00338-1005 |
80 mg/100mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 0338-1005-02
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0004-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dopamine recalls
See all
Class II · Moderate risk
Dopamine various strengths in dextrose
Lack of sterility assurance.
Class II · Moderate risk
Dopamine HCI active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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All 2014 recalls
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