Medication Recalls:
1. Midazolam: within this medication, a dangerous drug precipation with saccharin may cause serious adverse effects and/or death.
From Roche Laboratories: March 1, 2002
"Dear Health Care Professional:
Roche Laboratories is conducting a voluntary drug recall of VERSED Syrup, 188 mL (2 mg/mL) bottle, Lots U009-50 and U0010-50, which you may have received on or after December 27, 2001.
VERSED is indicated for use in pediatric patients [children] for sedation, anxiolysis and amnesia [to cause memory loss] prior to diagnostic, therapeutic or endoscopic procedures or before induction [administration] of anesthesia.
Roche is taking this action because of the potential presence of a crystalline precipitate of an insoluble complex of midazolam [the medication] and saccharin [a known cancer-causing artificial sweetener] inside the bottle. The presence of this precipitate causes a lack of uniformity in the product and may result in the administration of a super [too high] or sub-potent [too low] dose. The administration of a variable dose of VERSED Syrup may result in adverse consequences. Due to this possibility we are designating this as a Class I recall. A Class I recall is defined as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death..."
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.