Practitioners' Reporting News

Update: Implementation of Bentyl® Label Change

Issued January 11, 2001

Aventis Pharmaceuticals (formed in December 1999, from the merger of Hoechst Marion Roussel and Rhone-Poulenc Rorer) recently notified USP that a packaging date of February 1, 2001 is planned for the implementation of the return to the old-style labeling of its product Bentyl to include the 2-mL total volume on the label.

Beginning in April 1999, the USP Practitioners' Reporting NetworkSM (USP PRN®) started to receive reports concerning actual and potential errors involving the labeling of Bentyl® (dicyclomine hydrochloride) 2-mL ampuls. To date, 25 reports have beensubmitted by practitioners citing that the label on Bentyl indicates only the drug concentration, 10 mg/mL and not the total 2-mL volume of the ampul. Two of the more recent reports involved actual errors that occurred in emergency rooms. On both occasions, Bentyl 20 mg was ordered and the contents of two ampuls, for a total of 40 mg/4 mL, were administered because the vial was mistaken as a 1-mL vial without the 2 mL denotation appearing on the label.


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