Perrigo Acetaminophen Infant Suspension Liquid: Recall – Potential Defect with Co-packaged Oral Syringe

[Posted 11/02/2013]

AUDIENCE: Consumer, Patient, Pediatrics, Pharmacy, Health Professional

ISSUE: The Perrigo Company announced 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 under store brand products including Babies R Us, Care One and more  (refer to the Firm Press Release for full list of affected brand names and products).

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. Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.

BACKGROUND:  This over the counter 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.

RECOMMENDATION: If the oral dosing device contained in the package has dose markings (for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL), 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Press Release, at: