Class II · Moderate risk Ongoing
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For…
Reason Discoloration; discolored solution from cracked vials
DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
What was recalled
DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Recalling firm
- Sentara Enterprises
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0622-2016
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, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion…
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only…
Reason Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk Terminated
Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Dobutamine various strengths in dextrose
Reason Lack of sterility assurance.
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