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U.S. Department of Health and Human Services

Safety

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Versed Syrup (midazolam HCl) CIV

Audience: Anesthesiologists, pediatricians, and other healthcare professionals

Roche Laboratories is conducting a voluntary Class I drug recall of 118 mL (2mg/mL) bottle, lots U0009-50 and U0010-50, because of the potential presence of a crystalline precipitate of an insoluble complex of midazolam and saccharin 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 or sub-potent dose.

[March 1, 2002 - Recall Notice - Roche]