Safety Alert on Oral Drops with packaged Syringe

Again confusing packaging for children's medication causes the US Food and Drug Administration (FDA) to announce that the Perrigo Company has initiated a voluntary nationwide recall of all lots of concentrated infants' oral drops.

The medication effected by the recall is packaged with a dosing syringe bearing only a "1.6 mL" mark which may be confusing in determining the proper dose for infants less than 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing.

A physician who noticed the potential confusion that the packaged dosing syringe could cause filed a complaint with the American Academy of Pediatrics. The packaging and labeling allows safe dosing for 2-3 year olds weighing 24-35 lbs,

Even though the packaging for 2-3 year olds is safe, these products are also intended for use by children younger than 2 years and weighing less than 24 pounds and the labeling directs consumers to consult with their doctor for correct dosing directions for smaller infants.

The oral dosing syringe packaged with these products is not marked so as to accurately measure doses less than 1.6 mL. The prior packaging that enclosed a dropper, not the oral dosing syringe, was marked with two markings on it ("0.4 mL" and "0.8 mL"). The new package as a syringe with a single mark on has caused confusion among consumers and health-care professionals and may lead to improper dosing which may cause liver damage.

The medication contains acetaminophen; acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl; or dextromethorphan HBr, and pseudoephedrine HCl and on retail level effects the following medications:

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

The products were sold nationally 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, Walgreens, Western Family, and Winn Dixie.

A packaging professional not understanding how a customer uses his product and paying attention to small details caused this immense problem that endangered the health of small children and will cost the company untold millions to recall the existing packaging. I am glad it was not me.