The Perrigo Company announced today that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box. The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings.
Recalled product labels include Babies R Us, Care One, Equaline, Equate, Harmon Face Values, Health Mart, Healthy Accents, HEB, Kroger, Leader Drug, Meijer, Publix, Rite Aid, Topcare, Up and Up, and Walgreen.
The correct syringe should have a white or yellow plunger with specific dose markings for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL. If the product's syringe has these dose markings, consumers can continue to use the product while following labeled use 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.
Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.
Perrigo has not received any reports or complaints 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.
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: www.fda.gov/medwatch/report.htm1; if submitting via regular mail, use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm2, mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or fax: 1-800-FDA-0178.
For a complete list of batch numbers of the recalled products, visit the FDA website at http://www.fda.gov/Safety/Recalls/default.htm.