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Perrigo Initiates Nationwide Voluntary Product Recall Of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due To A Potential Defect With The Co-Packaged Oral Syringe
Date:11/1/2013

aints related to this defect nor have they found any product with missing dose markings on re-examination of product on hand.

This OTC product is indicated for the relief of fever and minor aches and pains and can be used in infants, children and adults. These recalled products are sold by distributors nationwide and distributed through retail stores.

Perrigo is notifying its distributors and customers by verbal and e-mail communication today, followed by formal FedEx-delivered communication. It also is arranging for return of all recalled products. Distributors/retailers that have the acetaminophen infant suspension liquid that is being recalled should stop distribution and return product.

If the oral dosing device contained in the package has dose markings, no action is required, and the consumer can continue to use the product consistent with the label instructions. If the package contains an oral dosing device that does not have dose markings, the consumer should not use the product and should call Perrigo's Consumer Affairs Department, toll free, 1-800-719-9260. Consumers should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.

Adverse events that may be related to the use of this product may be reported to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at:
    www.fda.gov/MedWatch/getforms.htm.
    Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
  • Fax: 1-800-FDA-0178
  • This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

    Recalled lots, along with their correspond
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    SOURCE Perrigo Company
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