FDA-Drug2017-10-11Class IIICHEMICAL
Pfizer Deferoxamine Mesylate injection recalled for uncontrolled impurity
OTHERNationwide distribution
Check Pfizer Deferoxamine Mesylate lot 51275DD
Pfizer's Deferoxamine Mesylate injection (500 mg/10 mL vials) is being recalled because the manufacturer failed to properly control an impurity that caused color changes during production. The affected lot (51275DD, expiring 09/01/17) was distributed nationwide. No injuries have been reported.
- If you have lot 51275DD, do not use it
- Contact your pharmacy or healthcare provider for guidance on your specific prescription
- Ask about alternative treatments if needed
Hazard
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Sold states
Nationwide
Affected count
32,276 10 mL vials
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2018Don't want to check this manually?
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