Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - No...
FDA Recall #D-0248-2025 — Class II — February 18, 2025
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.
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.
Recalling Firm
Turbare Manufacturing — Conway, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,147 syringes
Distribution
Nationwide in the USA
Code Information
Lot #s: 12122024@2 (BUD: 3/12/2025); 12192024@2 (BUD: 4/18/2025).
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated