CYTARAbine for Injection USP — Class II drug recall D-1543-2014
Terminated recall by Ben Venue Laboratories Inc, reported 2014-08-27, distributed nationwide. Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrit
| Recall number | D-1543-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ben Venue Laboratories Inc, Bedford, OH, United States |
| Recall initiated | 2014-07-31 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2014-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 7,172 vials |
| Reason classes | sterility |
| NDC | 55390-0808-01 |
| Lot numbers | 0161-13-2167551, 0161-13-2176919, 07/14, 08/14 |
Product
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
Reason for recall
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
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-1543-2014. 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.