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Recall Observatory FDA recall evidence

Drug 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

D-0051-2025

November 06, 2024

Class II

Product summary

Firm
Tailstorm Health INC
Event
Event 95718
Status
Terminated
Classification
Class II
Quantity
27,560 Syringes
Official record key
drug-enforcement:D-0051-2025

Official wording

Reason: Lack of Sterility Assurance

Code 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.

Distribution pattern: Nationwide Within U.S.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility