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3/1/2002

Roche Recalls Bottles of Midazolam Syrup

Cheryl A. Thompson

Two lots of Versed Syrup are being recalled by Roche Laboratories Inc. because of the possibility that doses poured from the bottles may not contain uniform amounts of midazolam hydrochloride.

In a "Dear Health Care Professional" letter (PDF) dated February 28, the company announced it is recalling lots U0009-50 and U0010-50, which are 118-mL bottles of midazolam 2 mg/mL with an expiration date of April 2003. Roche wants all bottles from these lots removed immediately from dispensing areas and returned to suppliers for credit. This recall does not apply to other Versed products.

The company said it determined that the syrup in the two lots could potentially contain a crystalline precipitate of a midazolam–saccharin complex. This precipitate, if present, would cause some portions of the syrup to contain more than 2 mg/mL of midazolam and other portions to contain less. The adminstration of an inappropriate dose of midazolam to a child may result in adverse consequences, the company indicated.