FDA recall D-0248-2025

Turbare Manufacturing · Class II · 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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Completed
Initiation date
2025-02-18
Report date
2025-03-05
Termination date
2026-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Conway, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2025