FDA Issues Safety Alert on Infants' Oral Drops Containing Enclosed Syringe
The Food and Drug Administration (FDA) has announced 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 two (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
* 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. 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 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
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.