Recall: D-1446-2020

Class II - Potentially Harmful

Class IIClassification

2020-07-20Initiated

TerminatedStatus

Pfizer Inc.Firm

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

Reason

Lack of Assurance of Sterility; potential loose metal overseal crimp defects.

Distribution

United States including Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.