Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25
Summary
The FDA issued a Class II for Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmace by Sagent Pharmaceuticals Inc. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0763-2023
Action Date
2023-05-31
Status
Ongoing
Category
drug
Product Description
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Lot/Code Info: Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;
Quantity Affected: 2,249,980 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-19
Company
Schaumburg, IL
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 216 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Sagent Pharmaceuticals Inc has 4 FDA actions in our database, including 4 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 (Sagent Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sagent Pharmaceuticals Inc have FDA actions?
Sagent Pharmaceuticals Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0763-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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