Class II · Moderate risk
DOBUTamine Injection
Discoloration; discolored solution from cracked vials
DOBUTamine Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
Affected NDC
0409-2344-02
Compare with the code on your package — it is the most precise check available.
Drug: Dobutamine
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 |
|---|---|---|---|---|
| Dobutamine NDC 00409-2344 |
HYDROCHLORIDE 12.5 mg/mL | Injection, Solution, Concentrate Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-2344-02
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1540-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dobutamine recalls
See all
Class II · Moderate risk
Dobutamine
Lack of sterility assurance
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Lack of Sterility Assurance.
Class II · Moderate risk
DOBUTAMINE HCL in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Other recalls by Hospira Inc.
All 2014 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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