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1/16/2001

Company Recalls Pediatric Cold Product

Cheryl A. Thompson

Great Southern Laboratories is recalling a single lot of the pediatric cold product Cydec Drops, distributed by Cypress Pharmaceutical Inc., because the dosage chart on the package is incorrect.

The outer carton of Cydec Drops lot no. 02950 incorrectly states that the product’s dropper, when full, contains the same volume as one full teaspoon, equivalent to about 5 mL. One milliliter of the product contains 2 mg of the antihistamine carbinoxamine maleate and 25 mg of the decongestant pseudoephedrine hydrochloride—a dose appropriate for children 9 months up to 6 years of age.

A dose of 5 mL would deliver too much of both ingredients, even for an adult.

The label of Cydec Drops lot no. 02950 also bears the National Drug Code 60258-439-30 and the expiration date December 2005.

Great Southern requests that pharmacies contact patients’ parents or caregivers to warn them about the recall and return the product. Consumers wanting further instructions or information may call the company at 800-747-0783.

A company spokesperson said that pharmacies should return their supplies of the recalled product to their wholesaler for credit.