Bevacizumab injection syringes recalled for lack of sterility assurance
27,560 bevacizumab injection syringes distributed nationwide are being recalled due to failure to maintain sterility assurance. The affected syringes may not be sterile.
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 sterile injectable product for lack of sterility assurance. Although no illnesses or injuries have been reported, sterile injections with compromised sterility represent a risk-of-harm product that could lead to infection or contamination if affected batches were used.
Plain-English summary
Tailstorm Health INC is recalling 27,560 bevacizumab (AVASTIN) 1.25mg/0.05mL sterile injection syringes distributed nationwide. The product is a single-dose syringe (0.5 mL) repackaged by Medivant Healthcare in Phoenix, Arizona, with NDC 81483-0041-1.
The recall is issued because the affected syringes lack sterility assurance. This means the manufacturing and repackaging process may not have maintained the required sterility standards for injectable medications, which could result in contamination.
The affected lot numbers are D24005 (Exp. 20 February 2025), D24006 (Exp. 21 February 2025), D24007 (Exp. 22 February 2025), D24008 (Exp. 19 March 2025), D24009 (Exp. 20 March 2025), and D24012 (Exp. 25 April 2025). Healthcare providers and patients in possession of affected syringes should contact their healthcare provider or Tailstorm Health INC regarding the appropriate course of action.
The recalled product
- Product
- BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Sterile Injection
- Hazard
- sterility-failure
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 (12)
- Lot #: D24005
- Exp. Date 20 February 2025
- D24006
- Exp. Date 21 February 2025
- D24007
- Exp. Date 22 February 2025
- D24008
- Exp. Date 19 March 2025
- D24009
- Exp. Date 20 March 2025
- D24012
- Exp. Date 25 April 2025.
Distribution
Distributed nationwide across the United States.
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