Class III · Low risk Terminated
Deferoxamine Mesylate for injection
Reason CGMP Deviations: Firm failed to control impurity for color change at the API stage.
DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Sterility of product is not assured.
What was recalled
DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
- Recalling firm
- Lincare, Inc.
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1183-2015
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 Deferoxamine recalls
See all
Class II · Moderate risk Terminated
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Deferoxamine 4 grams/NS 101 mL Cassette
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Deferoxamine 2 grams/51 mL NS cassette
Reason Lack of Sterility Assurance.
Class III · Low risk Terminated
Deferoxamine various strengths in normal saline
Reason Lack of sterility assurance.
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