FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

PERRIGO COMPANY RECALLS CHILDREN’S PAIN RELIEVER SUSPENSION LIQUID

NEWS RELEASE



Contact:  Ernest J. Schenk
          (616)673-9212

For Immediate Release

Perrigo Company Recalls Children's Pain Reliever Suspension Liquid

ALLEGAN, Mich.-August 15, 2001-Perrigo Company today announced that, in cooperation with the U.S. Food and Drug Administration (FDA), it is conducting a recall of 7,788 four-ounce bottles of cherry-flavored pain reliever suspension liquid with Lot Number 1AD0228.

Perrigo determined that this lot may contain an excess of up to 29 percent over the labeled amount of acetaminophen. The product is being recalled because overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure.

The product, which is used to treat headaches and fevers in children, was sold under the Good Sense® label at various small independent retail chains across the country, under the Hy-Vee® label at Hy-Vee stores in Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska and South Dakota and under the Kroger® label at Kroger stores in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Texas, Virginia and West Virginia.

Perrigo immediately notified the FDA as well as the retailers and wholesale distributors of this product. No consumer complaints have been reported.

Of the 7,788 bottles affected in this recall, Perrigo estimates that approximately 6,500 were purchased by consumers. The rest have been removed from retailers’ shelves and inventory.

Consumers who purchased bottles with Lot Number 1AD0228, which is printed on each bottle’s label and carton, are urged to discontinue use of the product immediately and return it to the place of purchase for a full refund. Consumers with questions may contact Perrigo at 1-800-321-0105.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch/index.html.

FDA/Website Management Staff
Web page created by tg 2001-AUG-16.