WhichRecall
Class IIReported 2025-03-05

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.

Recalled by Turbare Manufacturing

Reason for Recall

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

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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.

Recall Number
D-0248-2025
Classification
Class II
Status
Completed
Category
drug
Initiated
2025-02-18
Reported
2025-03-05
Distribution
Nationwide in the USA
Code Info
Lot #s: 12122024@2 (BUD: 3/12/2025); 12192024@2 (BUD: 4/18/2025).
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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