Leucovorin Calcium Injection USP — Class II drug recall D-036-2013
Terminated recall by Ben Venue Laboratories Inc, reported 2012-11-07, distributed nationwide. Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate
| Recall number | D-036-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ben Venue Laboratories Inc, Bedford, OH, United States |
| Recall initiated | 2012-07-05 |
| Classified | 2012-11-01 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 226,010 vials |
| Reason classes | specification failure |
| NDC | 55390-0009-01, 55390-0826-01 |
| Lot numbers | 2017619, 2017620, 2017621, 2038374, 2038374A, 2038375, 2065418, 2067176, 2067177, 2067178A |
| Model numbers | 0967-57-2017619, 0967-57-2017621, 0967-57-2038375, 0967-57-2065418, 0967-57-2067176, 0967-57-2067177, 0967-57-2067178A |
| Expiration dates | 2012-11, 2013-01, 2013-02, 2013-03, 2013-06 |
Product
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
Reason for recall
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
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-036-2013. 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.