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FDA Safety Alert on Infants’ Oral Drops with Syringe

The U.S. Food and Drug Administration (FDA) is announcing that the Perrigo Company has initiated a voluntary nationwide recall of all lots of concentrated infants’ oral drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing acetaminophen; acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl; or dextromethorphan HBr, and pseudoephedrine HCl.

The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. The following products are being recalled to the retail level:

  • Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
  • Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
  • Cherry Flavor Cough and Cold Infant Drops (0.5oz)
  • Cherry Flavor Decongestant and Cough Infant Drops (0.5oz)

The directions on the bottle and carton labeling for infants ages 2-3 years and weighing 24-35 pounds allow safe and effective dosing for this age and weight group. However, these products are also intended for use by children younger than 2 years and weighing less than 24 pounds. The labeling directs consumers to ask a doctor for dosing directions for this age and weight group.

The oral dosing syringe enclosed with these products is not marked so as to accurately measure doses less than 1.6 mL when prescribed by physicians for infants younger than 2 years and weighing less than 24 pounds. Until recently these products were provided with a dropper, not the oral dosing syringe, and the dropper had two markings on it (“0.4 mL” and “0.8 mL”). The single mark on the current syringe along with the changeover from the dropper to this syringe has caused some confusion among consumers and health-care professionals and may lead to improper dosing. Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage. Consumers who have questions should discuss this with their doctor to accurately determine proper dosage.

In using an alternative over-the-counter product, parents and doctors should thoroughly discuss the specifics about the product and the dosing device, particularly the labeling and marking, so that the proper dose can be measured and administered correctly.

The confusion of the dosing syringe was noted after a physician filed a complaint with the American Academy of Pediatrics.

The recalled products were sold nationally at retail chains under the following store-brand labels: American Fare, Best Choice, Brooks, Berkley & Jensen, CVS, Dollar General, Eckerd, Equaline, Equate, Family Dollar, Food Lion, Good Neighbor, GoodSense, Healthy Generations, Health Pride, Hy-Vee, Kroger, Leader, Longs, Major, Medicine Shoppe, Meijer, Parklane, Publix, Rite Aid, Safeway, Shop Rite, Sunmark, Target, Today’s Health, Top Care, Walgreen, Western Family, and Winn Dixie.

Perrigo is cooperating with the FDA in this recall and in the effort to alert consumers and retailers about this issue. Questions or concerns about a product described in this recall should be directed to Perrigo’s Consumer Affairs Department, toll free, at 800-321-0105. Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane , Rockville , MD 20852-9787

Source: FDA Issues Safety Alert on Infants’ Oral Drops Containing Enclosed Syringe

Posted: August 2005

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