Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection,...
FDA Recall #D-0097-2023 — Class II — December 29, 2022
Product Description
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 for Recall
Lack of assurance of sterility: Bags have the potential to leak.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
62,088 bags
Distribution
Nationwide in the USA.
Code Information
Lot: 5935283, Exp. 12/01/2023
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated