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Recall Observatory FDA recall evidence

Drug product

Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.

D-0248-2025

February 18, 2025

Class II

Product summary

Firm
Turbare Manufacturing
Event
Event 96306
Status
Completed
Classification
Class II
Quantity
1,147 syringes
Official record key
drug-enforcement:D-0248-2025

Official wording

Reason: Lack of Assurance of Sterility: due to a quality control process deviation

Code information: Lot #s: 12122024@2 (BUD: 3/12/2025); 12192024@2 (BUD: 4/18/2025).

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    process deviation
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility