Company: Tri-Med Laboratories Inc
Product: “PSE Carbinoxamine DM Syrup,” “Carbodex DM Syrup,” “Ronddamine DM Syrup” and other drugs
Date: 4/28/04
Your investigation report for failing Pediahist lot F312 indicates that the batch was formulated superpotent because the manufacturing order sheet was reproduced from another product format on a computer, hence the incorrect amounts of ingredients were carried forward. Although, the Pediahist lot F312 manufacturing order includes the signatures of yourself and another individual who prepared and reviewed the manufacturing order prior to manufacturing, the error was not found until the batch was compounded and a portion of the batch was filled. We are extremely concerned by the apparent lack of appropriate master production records and systems to prevent such errors from occurring. The corrective action documented in your firm’s investigation report states that in the future utmost care would be taken for preparation and review of the documents for formulations and bulk manufacturing. However, there is no mention of any specific measures that will be taken to prevent a recurrence of such an error. Moreover, there is no indication that your investigation of this error was extended to other lots and products that have been manufactured by your firm. Considering that your operations allowed for such an error, it is critical that appropriate measures be taken to ensure that similar formulation errors have not occurred in other products marketed by your firm.
FDA District: New Jersey District Office
