August 14, 2020
Pfizer Inc. is recalling more than 19,000 vials of fentanyl citrate injection due to a lack of sterility assurance. The August 12, 2020, US Food and Drug Administration (FDA) Enforcement Report cites “potential loose metal overseal crimp defects.”
The recall affects fentanyl citrate injection, 100 mcg fentanyl/2 mL (50 mcg/mL), 2-mL single-dose flip-top vials (NDC 0409-9094-12), from tray lot 13405DK, vial lot 13-405 DK (Exp. 7/1/21), and tray lot 17096DK, vial lot 17-096-DK (Exp. 11/1/21). The product was distributed by Hospira Inc. throughout the United States, including Puerto Rico.
Pfizer voluntarily initiated the recall July 20, 2020. On August 4, 2020, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Fentanyl citrate is a prescription analgesic injection used during anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period.