July 2020 FDA Recall Fentanyl Citrate by Pfizer Inc.
D-1446-2020 - Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
This Class II drug recall was voluntarily initiated by Pfizer Inc. on July 20, 2020 for the product Fentanyl Citrate. The FDA reported the reason for recall as lack of assurance of sterility; potential loose metal overseal crimp defects.. The product was distributed in United States including Puerto Rico and the recall is currently terminated.
Recall Number: D-1446-2020
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
07-20-2020
08-12-2020
19,144 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States including Puerto Rico
12-08-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
