Reported Nov 7, 2012 · Terminated
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc.,…
Ben Venue Laboratories Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ben Venue Laboratories Inc · 300 Northfield Rd · Bedford, OH · 44146
Is this the product you have?
- Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only
- Manufactured byBen Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published 0967-57-2017619Lot #, 2017619 (Bedford), Mfr , NDC, 55390-009-01, Exp. Date 11/2012 — Lot# 2017620, Exp. Date 1/2013, NDC #55390-009-01 0967-57-2017621Lot #, 2017621 (Bedford), Mfr , NDC, 55390-009-01, Exp Date 01/2013 — Lot #2038374, exp. 2/2013, NDC #55390-009-01 — Lot #2038374A, exp. 2/2013, NDC #55390-826-01 Note: 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling) 0967-57-2038375Lot #, 2038375 (Bedford), Mfr , NDC, 55390-009-01, Exp Date 03/2013 0967-57-2065418Lot #, 2065418 (Bedford), Mfr , NDC, 55390-009-01, Exp Date 06/2013 0967-57-2067176Lot #, 2067176 (Bedford), Mfr , NDC, 55390-009-01, Exp Date, 06/2013 0967-57-2067178ALot #, 2067177 (Bedford), Mfr Item # 0967-57-2067177, NDC, 55390-009-01, Exp Date 06/2013 & Lot #, 2067178A (Novaplus), Mfr , NDC, 55390-826-01, Exp Date, 06/2013. - Amount recalled
- 226,010 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
This product could cause temporary or reversible health problems — stop using it.
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