Great Southern Laboratories Recalling Cydec Drops a Prescription Pediatric Cold Drug.

Business Editors & Health/Medical Writers

HOUSTON--(BUSINESS WIRE)--Jan. 12, 2001

Great Southern Laboratories, a Houston pharmaceutical manufacturer, is voluntarily recalling all bottles of Cydec Drops, Lot No. 02950, a prescription drug which it made exclusively for Cypress Pharmaceutical Inc. The product is a one-ounce bottle and calibrated dropper packaged in a carton, all bearing Cypress Pharmaceutical Inc. labeling.

Great Southern Laboratories initiated the recall upon learning that the outer carton in which each Cydec Drops bottle was packaged from Lot No. 02950 bore an incorrect dosage correlation chart. The chart incorrectly equates a dropperful and partial dropperfuls to a teaspoonful and partial teaspoonfuls. If, instead of using the dropper that is packaged in the carton containing the Cydec Drops bottle, a consumer used the incorrect chart to determine how much of the medication to give a child using a teaspoon, an overdose could occur. Overdoses of this medication can cause serious illness or death, depending on a number of factors including the health of the pediatric patient and the extent of the overdose. Great Southern Laboratories has not received any reports of illness in connection with this labeling error.

Any consumer in possession of Cydec Drops, Lot No. 02950, is asked to discontinue use of this product and return it their pharmacist. In addition, consumers may call Great Southern Laboratories at 800/747-0783 for further instructions information.

Only Cydec Drops from Lot No. 02950 are involved in this recall. The product label bears NDC No. 60258-439-30, with an expiration date of 12/2005. Each one-ounce bottle contains 2 mg. of carbinoxamine maleate (an antihistamine) and 25 mg. pseudoephedrine hydrochloride (a decongestant) in each 1 ml of product.

Great Southern Laboratories is conducting the recall with the knowledge of the U.S. Food & Drug Administration. Cypress distributed 6,135 one-ounce bottles of the antihistamine/decongestant prescription drug product to wholesalers for national distribution to pharmacies beginning on Dec. 19, 2000. All pharmacies that received any shipments of Cydec Drops after Dec. 19, 2000, are being contacted. The pharmacies, in turn, are asked to contact their customers to ensure that Cydec Drops from Lot No. 02950 are not used and, instead, are returned.