BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repac...
FDA Drug Recall #D-0051-2025 — Class II — November 6, 2024
Recall Summary
| Recall Number | D-0051-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 6, 2024 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tailstorm Health INC |
| Location | Phoenix, AZ |
| Product Type | Drugs |
| Quantity | 27,560 Syringes |
Product Description
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
Reason for Recall
Lack of Sterility Assurance
Distribution Pattern
Nationwide Within U.S.
Lot / Code Information
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.
Other Recalls from Tailstorm Health INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0500-2025 | Class II | KETAmine Hydrochloride Injection, USP, 50 mg/5m... | Jun 2, 2025 |
| D-0502-2025 | Class II | LIDOcaine HCL Sterile Injection, USP, 100mg/10m... | Jun 2, 2025 |
| D-0501-2025 | Class II | KETAmine Hydrochloride Injection, USP, 500mg/5m... | Jun 2, 2025 |
| D-0499-2025 | Class II | BUPIVAcaine HCL Sterile injection, USP w/EPINEP... | Jun 2, 2025 |
| D-0498-2025 | Class II | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 ... | Jun 2, 2025 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.