Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Reported: August 12, 2020 Initiated: July 20, 2020 #D-1446-2020
Product Description
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Reason for Recall
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 19,144 vials
- Distribution
- United States including Puerto Rico
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12. Recalled by Pfizer Inc.. Units affected: 19,144 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 12, 2020. Severity: Moderate. Recall number: D-1446-2020.
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