Turbare Manufacturing: Drug Recall

Recall #D-0248-2025 · 02/18/2025

Class II: Risk

Recall Details

Recall Number
D-0248-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Turbare Manufacturing
Status
Completed
Date Initiated
02/18/2025
Location
Conway, AR, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,147 syringes

Reason for Recall

Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.

Product Description

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.