Recall: D-0097-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-29Initiated

CompletedStatus

Pfizer Inc.Firm

Product

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

Reason

Lack of assurance of sterility: Bags have the potential to leak.

Distribution

Nationwide in the USA.

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