Avastin intravitreal injection syringes recalled for sterility assurance failure
Turbare Manufacturing recalls 1,147 syringes of Avastin 1.25 mg intravitreal injection nationwide due to a quality control process deviation affecting sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterility-critical product (intravitreal injection) due to a quality control deviation. No illnesses or injuries have been reported. The hazard is theoretical, fitting the criterion for High (3) rather than Severe (4), which requires reported hospitalizations.
Plain-English summary
Turbare Manufacturing has recalled 1,147 syringes of Avastin 1.25 mg/0.05 mL for intravitreal injection (National Drug Code 83556-0101-01), distributed nationwide. The affected syringes include two lots: 12122024@2 (beyond-use date March 12, 2025) and 12192024@2 (beyond-use date April 18, 2025).
The recall was initiated due to a quality control process deviation affecting sterility assurance. Avastin is administered directly into the eye, making sterility critical to patient safety.
Healthcare providers with affected syringes should discontinue use immediately and contact their supplier. Patients who received injections from affected lots should contact their eye care provider.
The recalled product
- Product
- 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.
- Manufacturer
- Turbare Manufacturing
- Category
- Drug — Intravitreal Injection
- Hazard
- loss-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #s: 12122024@2 (BUD: 3/12/2025)
- 12192024@2 (BUD: 4/18/2025).
Distribution
Distributed nationwide across the United States.
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