Key Takeaway

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 Driv by Turbare Manufacturing was recalled on February 18, 2025. The hazard: Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (...

FDA Drug Class II Completed

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 Driv

Recalled: February 18, 2025 ~1,147 syringes units affected D-0248-2025

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.

Hazard / Reason

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.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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 Driv

Drugs

Company Information

Turbare Manufacturing

Conway, AR, United States

View all 1 recalls by Turbare Manufacturing →

Distribution

Nationwide in the USA

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Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

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