November 2024 FDA Recall Drug by Tailstorm Health Inc
D-0051-2025 - Lack of Sterility Assurance

This Class II drug recall was voluntarily initiated by Tailstorm Health Inc on November 6, 2024 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0051-2025

Reason for Recall
Lack of Sterility Assurance
Initiated
11-06-2024
Reported
11-27-2024
Quantity
27,560 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95718
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tailstorm Health INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide Within U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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.