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,

FDA recall notice · announced January 11, 2023 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot: 5935283, Exp. 12/01/2023
Quantity: 62,088 bags
Status: Completed
Products in this recall event:
- 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 (D-0097-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.