Why it was recalled
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
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
Lot numbers, UPCs & expiration codes
Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
Where it was sold
United States including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1446-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 20, 2020
- FDA report date
- Aug 12, 2020
- Quantity
- 19,144 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1446-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86074
- Address
- 235 E 42nd St
- Code information
- Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
- Postal code
- 10017-5703
- Report date
- Aug 12, 2020
- Product type
- Drugs
- Recall number
- D-1446-2020
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 19,144 vials
- Termination date
- Dec 8, 2022
- Reason for recall
- Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- United States including Puerto Rico
- Recall initiation date
- Jul 20, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2020