# FDA recall D-036-2013

> **Ben Venue Laboratories Inc** · Class II · drug recall initiated 2012-07-05.

## 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.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-036-2013
- **Recalling firm:** Ben Venue Laboratories Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-05
- **Report date:** 2012-11-07
- **Termination date:** 2013-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-036-2013

## Citation

> AI Analytics. FDA recall D-036-2013. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-036-2013. Source: US FDA. Licensed CC0.

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