UDL LABS' REPACKAGED DRUGS MUST IDENTIFY MANUFACTURER

Executive Summary

UDL LABS' REPACKAGED DRUGS MUST IDENTIFY MANUFACTURER in the product packaging, FDA told the Rockford, Illinois-based firm in a March 12 regulatory letter. FDA cited three drug products (4 mg chlorpheniramine maleate, 5 mg diazepam tabs, and 12.5 mg meclazine tabs) as misbranded "in that the labels (unit-dose package) fail to bear the place of business of the manufacturer, packer, or distributor as required." The packaging for the three drug products does include the name of UDL. However, FDA said that the company violated the FD&C Act "by failing to qualify the name 'UDL Labs, Inc.'" The packaging, FDA maintains, "represents that UDL Labs is the manufacturer, [which] is contrary to the fact." Noting that UDL has argued that its unit-dose labels "are too small to accommodate all the required information," FDA said it believes "that a careful review of each label will indicate that by rearrangement of the information on the label and a judicious utilization of the label space, all the required information can be accommodated." The agency is requesting UDL to examine all its unit-dose labels and advise FDA "which labels [the firm] will revise to accommodate all the information" and provide FDA with "a sample of each with the revised information." The agency also is asking for samples of labeling that UDL feels are too small to include the required information. The reg letter provides UDL with the standard 10 days to report to FDA what action the firm "will take to revise the labels" and "dispose of...stocks of misbranded drug products." The agency asks that the firm's reply include: an estimate of the quantity of drug received and packaged in unit-dose containers within the past 12 months; an estimate of the size and frequency of shipments for each drug made by the company in the last 12 months; an estimate of the amount of drug in inventory and distribution; and the date of discontinuance if a product has already been discontinued.