Recalls / Class II
Class IID-0835-2020
Product
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).
- Affected lot / code info
- Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.
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.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 38,676 trays
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico
Timeline
- Recall initiated
- 2020-02-03
- FDA classified
- 2020-02-10
- Posted by FDA
- 2020-02-19
- Terminated
- 2022-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0835-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.