Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations
Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling 32,276 vials of Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. The product is identified by Lot 51275DD and has an expiration date of 09/01/17. The recall covers vials distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm failed to control an impurity responsible for color change at the active pharmaceutical ingredient (API) stage. This is classified as an FDA Class III recall, which indicates a violation of CGMP or the Federal Food, Drug, and Cosmetic Act that is not likely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected product and contact Pfizer or their local FDA office for further instructions. The product is intended for intravenous, intramuscular, or subcutaneous use and is available by prescription only.
The recalled product
- Product
- 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.
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 51275DD
- Exp. 09/01/17
Distribution
Distributed nationwide across the United States.
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