February 20, 2013
The U.S Food and Drug Administration (FDA) and Gilead Sciences, Inc. announced last Friday they are conducting a voluntary recall of cidofovir injections, labeled under the name Vistide®, due to a defect. According to an FDA press release, some vials of the drug from particular lots contained particulate material in the solution.
The drug is a clear, colorless solution that is used in the treatment of patients suffering from both cytomegalovirus (CMV) retinitis and acquired immunodeficiency syndrome (AIDS). The contamination of the drug was not discovered until testing of lot # B120217A, carrying an expiration date of May 2015, was conducted. Experts say injection of the particulate could lead to a patient suffering drug injuries, including death, and added the severity of the Drug Injury could depend on how much and the size of the particular was injected.
Officials say that any vial of the drug should be inspected for particulate before use. Anyone who is in possession of an affected product has been instructed to contact Stericycle at 1-888-965-5791, Monday through Friday from 8:00 a.m. to 8:00 p.m. Eastern Time, to receive replacements of the medication. Anyone who experiences adverse health events as the result of the use of the drug is instructed to contact the FDA to report the incident.
Fleschner, Stark, Tanoos & NewlinN/a
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