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)
Reported: November 7, 2012 Initiated: July 5, 2012 #D-036-2013
Product Description
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.
Details
- Recalling Firm
- Ben Venue Laboratories Inc
- Units Affected
- 226,010 vials
- Distribution
- Nationwide and Puerto Rico.
- Location
- Bedford, OH
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Ben Venue Laboratories Inc. Units affected: 226,010 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 7, 2012. Severity: Moderate. Recall number: D-036-2013.
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