BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Heal
Summary
The FDA issued a Class II for BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syring by Tailstorm Health INC. Reason: Lack of Sterility Assurance.
Details
Source
Drug Recall
External ID
D-0051-2025
Action Date
2024-11-27
Status
Terminated
Category
drug
Product Description
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1
Lot/Code Info: Lot #: D24005, Exp. Date 20 February 2025; D24006, Exp. Date 21 February 2025; D24007, Exp. Date 22 February 2025; D24008, Exp. Date 19 March 2025; D24009, Exp. Date 20 March 2025; D24012, Exp. Date 25 April 2025.
Quantity Affected: 27,560 Syringes
Reason for Recall
Lack of Sterility Assurance
Distribution
Nationwide Within U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
Phoenix, AZ
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 166 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Tailstorm Health INC has 8 FDA actions in our database, including 8 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 (Tailstorm Health INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tailstorm Health INC have FDA actions?
Tailstorm Health INC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0051-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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