Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Reported: August 27, 2025 Initiated: August 4, 2025 #D-0590-2025
Product Description
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Reason for Recall
Lack of Assurance of Sterility.
Details
- Recalling Firm
- PFIZER INC
- Units Affected
- 49,620 vials
- Distribution
- U.S. Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.. Recalled by PFIZER INC. Units affected: 49,620 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2025. Severity: Moderate. Recall number: D-0590-2025.
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