Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcar
Summary
The FDA issued a Class III for Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx by Baxter Healthcare Corporation. Reason: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial..
Details
Source
Drug Recall
External ID
D-1103-2023
Action Date
2023-08-30
Status
Completed
Category
drug
Product Description
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Lot/Code Info: Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Quantity Affected: 13,502 vials
Reason for Recall
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Distribution
Nationwide in the U.S.A.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-14
Company
Deerfield, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1103-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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