D-0097-2023 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- January 11, 2023
- Initiation Date
- December 29, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62,088 bags
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 5935283, Exp. 12/01/2023