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.
Reported: October 11, 2017 Initiated: July 12, 2017 #D-0001-2018
Product Description
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.
Reason for Recall
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 32,276 10 mL vials
- Distribution
- Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pfizer Inc.. Units affected: 32,276 10 mL vials.
Why was this product recalled? ▼
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 11, 2017. Severity: Low. Recall number: D-0001-2018.
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