Recalls / Class II
Class IID-1446-2020
Product
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
- Brand name
- Fentanyl Citrate
- Generic name
- Fentanyl Citrate
- Active ingredient
- Fentanyl Citrate
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-9094, 0409-9093
- FDA application
- NDA019115
- Affected lot / code info
- Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
Why it was recalled
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 19,144 vials
- Distribution pattern
- United States including Puerto Rico
Timeline
- Recall initiated
- 2020-07-20
- FDA classified
- 2020-08-04
- Posted by FDA
- 2020-08-12
- Terminated
- 2022-12-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1446-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.