Recall 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.
Recall D-0248-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0248-2025 |
| Event ID | 96306 |
| Distribution | Nationwide in the USA |
| Quantity | 1,147 syringes |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20250305 |
| Recall Initiation Date | 20250218 |
| Report Date | 20250305 |
| Classification Date | 20250221 |
| Address | 925 Jeanette DrN/A Conway, AR 72032-6651 United States |
| Recalling Firm | Turbare Manufacturing |
| Initial Notification | |
| Similar To |