Compounded bevacizumab syringes recalled for lack of assurance of sterility
Fagron Sterile Services bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL single-dose syringes, is recalled nationwide for lack of assurance of sterility. 109,320 syringes are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an injectable medicine is a potential harm and no injuries are reported.
Plain-English summary
Bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL with a 0.12 mL fill, in sterile single-dose syringes from Fagron Sterile Services of Wichita, Kansas, is being recalled. Affected lots include C274-000044756 and C274-000044757 expiring 8-30-2025 and C274-000044832 and C274-000044833 expiring 9-4-2025, with the full list in the recall notice. The recall covers 109,320 syringes distributed nationwide.
The recall was issued for lack of assurance of sterility. The FDA classified the action as Class II.
Clinics and pharmacies holding these lots should quarantine them, stop using them, and follow the compounder's instructions for return.
The recalled product
- Product
- bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
- Manufacturer
- Fagron Compounding Services
- Category
- Drug — Compounded Injectable
- Affected units
- 109,320
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 (20)
- Lot #: C274-000044756
- C274-000044757
- Exp 8-30-2025
- C274-000044832
- C274-000044833
- Exp 9-4-2025
- C274-000044882
- C274-000044883
- Exp 9-6-2025
- C274-000044972
- Exp 9-8-2025
- C274-000045004
- C274-000045005
- Exp 9-18-2025 C274-000045108
- exp. date 9-13-2025 C274-000045109
- exp. date 9-13-2025 C274-000045136
- exp. date 9-14-2025 C274-000045137
- exp. date 9-14-2025 C274-000045289
- exp. date 9-20-2025 C274-000045290
- exp. date 9-20-2025 C274-000045350
Distribution
Distributed nationwide across the United States.
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