Perrigo Recalls Childrens Products

August 8, 2005
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ALLEGAN — The U.S. Food and Drug Administration announced Monday that Perrigo Co. had voluntarily initiated a nationwide, retail level recall of all lots of concentrated infants’ oral drops, which included four types of liquid pain, cough and cold drops packaged with a dosing syringe.

The oral dosing syringe bore a “1.6 mL” mark but no other markings to accurately measure doses less than 1.6mL, thus leading to some confusion among consumers and health-care professionals as to proper dosage for infants under age 2 weighing less than 24 pounds.

The products contain acetaminophen; acetaminophen, dextromethorphan HBr and pseudoephedrine HCI; or dextromethorphan HBr and pseudoephedrine HCI.

Products recalled were:

  • Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen
  • Grape Flavor Infant Pain Reliever 160 mg Acetaminophen
  • Cherry Flavor Cough and Cold Infant Drops
  • Cherry Flavor Decongestant and Cough Infant Drops.

“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 FDA stated. “Taking more than the recommended dose of acetaminophen (overdose) may cause liver damage.”

The products themselves are safe and effective when accurately dosed, said Ernest Schenk, Perrigo’s director of investor relations. Perrigo’s labeling on the products directed consumers to consult a physician for dosing directions for children in the under-2, under-25-pound category.

He said Perrigo submitted a Securities and Exchange Commission filing regarding the recall, and that the company estimates the recall effort will cost approximately $2 million.

Until recently, the four products in question were packaged with a dropper that had two markings — “0.4 mL” and “0.8 mL.” The single mark on the syringe, combined with the changeover from dropper to syringe caused some confusion, both Perrigo and the FDA acknowledged.

Schenk said Perrigo converted to the syringe in February of this year.

According to the FDA, a physician filed a complaint with the AmericanAcademy of Pediatrics after recognizing the potential for misunderstanding.

The FDA noted that Perrigo is cooperating with the agency on the recall, as well as with retailer alert efforts.

“We’re asking retailers to sweep the shelves and their warehouses of the products,” Schenk said, adding that consumers can return the product to their retail store for a full refund.

The recalled products were sold nationally at retail chains under 33 different store-brand labels, including Best Choice, CVS, Family Dollar, Kroger, Meijer, Equate, Rite Aid, Safeway, Shop Rite, Target, Walgreen, Top Care, Food Lion, Good Neighbor and Winn Dixie, among others.

When the recall effort is completed, Perrigo will go back to packaging those products with a dropper instead of the syringe in order to be consistent with the branded version of the products, Schenk noted.

“We’ll have to bring the product back and destroy it because it has to be re-labeled. There is nothing wrong with the product, but the dosing directions will change, which means we have to re-label it.”

Schenk said its difficult to quantify the volume of product involved in the recall because the company doesn’t know exactly how much is on retailers’ shelves or out in the field in consumers’ hands.

In November 2004 Perrigo initiated a retail level recall of its loratadine syrup product, an effort Schenk said cost the company some $8 million.

Perrigo is the world’s largest manufacturer of over-the counter pharmaceutical and nutritional products for the store brand and contract manufacturing markets. Perrigo also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products.    

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