Cheryl A. Thompson
BETHESDA, MD 05 July 2012—Bedford Laboratories, a distributor of products made by Ben Venue Laboratories Inc., on July 3 announced a recall of three lots of 50-mL leucovorin calcium injection single-dose vials: 2017620, 2038374, and 2038374A.
Visible crystalline particulate matter was discovered in a "small number" of vials in the lots, Bedford said.
The particulate matter, the company said, turned out to be the drug itself.
Bedford said it learned of the particulate matter from a complaint submitted to the company and confirmed the problem in a sample that had been retained.
The company said health care professionals who have vials from any of the three lots should immediately quarantine the vials for return. Questions should be directed to Bedford at 800-562-4797, 8 a.m. to 5 p.m. ET Monday through Friday.
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