Class II · Moderate risk Ongoing
DOBUTamine Injection
Reason 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.
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
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-2344-02
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1540-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dobutamine recalls
See all
Class II · Moderate risk Terminated
Dobutamine
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
DOBUTamine Injection
Reason Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk Terminated
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
DOBUTAMINE HCL in D5W
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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