Perrigo Acetaminophen Recall Prompted By Dosing Concerns
This article was originally published in The Tan Sheet
Executive Summary
Perrigo has initiated a voluntary recall of all lots of its concentrated infants' oral drops products in conjunction with an FDA safety alert issued Aug. 1
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Perrigo has initiated a voluntary recall of all lots of its concentrated infants' oral drops products in conjunction with an FDA safety alert issued Aug. 1. The liquid products being recalled are administered with a syringe that is labeled in a manner that may cause dosing confusion, FDA said. The syringe is not marked to measure doses smaller than 1.6 ml, which are necessary for infants younger than two years old and weighing less than 24 pounds. The syringe, therefore, "may be confusing in determining the proper dose for infants under two years of age as directed by a doctor and could lead to improper dosing, including overdosing," the agency noted. Products included in the Class II recall are Infant Pain Reliever 160 mg acetaminophen (0.5 oz and 1.0 oz) in grape and cherry flavors. Perrigo also is recalling Cough & Cold Infant Drops (acetaminophen, dextromethorphan and pseudo-ephedrine) and Decongestant & Cough Infant Drops (dextromethorphan and pseudoephedrine). A total of approximately 1.7 mil. dosage units were recalled. The product formerly was sold with a dropper that bore a mark for smaller doses of 0.4 mL and 0.8 mL. The new syringe bears only the 1.6 mL mark. "The single mark on the current syringe along with the changeover from the dropper to this syringe has caused some confusion among consumers and healthcare professionals and may lead to improper dosing," FDA stated. The safety alert was prompted by a physician complaint to the American Academy of Pediatrics. Concerns about improper dosing of acetaminophen, which can cause liver damage if taken in excess, also led to the recent recall of all lots of Tylenol Meltaways and a labeling revision that clarified proper dosing. McNeil Consumer & Specialty Pharmaceuticals announced in June it would change the product's label from "medicine per dose 80 mg" to "medicine per tablet 80 mg" in order to explain that each individual Meltaway tablet contains 80 mg (1 (Also see "Tylenol Meltaways, Soft Chews Recalled Due To Potential Dosing Errors" - Pink Sheet, 6 Jun, 2005.), p. 3). |