Bevacizumab — Class II drug recall D-1040-2013
Terminated recall by Leiter's Pharmacy, reported 2013-09-25, distributed nationwide. Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investiga
| Recall number | D-1040-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leiter's Pharmacy, San Jose, CA, United States |
| Recall initiated | 2013-08-26 |
| Classified | 2013-09-13 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 265 vials |
| Reason classes | microbial contamination, sterility, specification failure |
| Expiration dates | 2013-11-03 |
Product
Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Reason for recall
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1040-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.