Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Leucovorin Calcium Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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)
Affected NDCs
55390-0009-01
55390-0826-01
Compare with the code on your package — it is the most precise check available.
Drug: Leucovorin
- Recalling firm
- Ben Venue Laboratories Inc
- NDC code
- 55390-009-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-036-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Leucovorin recalls
See all
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin 15mg 24
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Ben Venue Laboratories Inc
All 2012 recalls
Class II · Moderate risk
CYTARAbine for Injection USP
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Class I · High risk
Acetylcysteine Solution
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Class I · High risk
Vecuronium Bromide for Injection
Presence of Particulate Matter
Class II · Moderate risk
Octreotide Acetate Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
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