Hospira, Inc. (a Pfizer company) is recalling 32,276 vials of Deferoxamine Mesylate for injection, USP (500 mg per 10 mL vial). This medication, used to treat iron toxicity, is being recalled because the manufacturer failed to control an impurity that caused a color change during the production of the active ingredient. Using a medication with uncontrolled impurities may not provide the expected therapeutic effect or could lead to unexpected side effects.
The presence of an uncontrolled impurity at the active pharmaceutical ingredient (API) stage indicates a failure in quality control, which can alter the drug's safety profile or effectiveness. While this specific issue is classified as low risk, the deviation from Good Manufacturing Practices means the product does not meet quality standards.
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Sources: FDA iRES · Raw API Response
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