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
Summary
The FDA issued a Class II for Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Ch by Pfizer Inc.. Reason: Lack of assurance of sterility: Bags have the potential to leak..
Details
Source
Drug Recall
External ID
D-0097-2023
Action Date
2023-01-11
Status
Completed
Category
drug
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,
Lot/Code Info: Lot: 5935283, Exp. 12/01/2023
Quantity Affected: 62,088 bags
Reason for Recall
Lack of assurance of sterility: Bags have the potential to leak.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-29
Company
New York, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pfizer Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pfizer Inc. have FDA actions?
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0097-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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