Why it was recalled
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Product description
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
Lot numbers, UPCs & expiration codes
Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.
Where it was sold
Nationwide in the U.S. and 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-0835-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 3, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 38,676 trays
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0835-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84833
- Address
- 235 E 42nd St
- Code information
- Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.
- Postal code
- 10017-5703
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0835-2020
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 38,676 trays
- Termination date
- Sep 29, 2022
- Reason for recall
- Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico
- Recall initiation date
- Feb 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2020