Recalls

Infant acetaminophen liquid recalled due to potential defect with oral syringe

Recall infant Perrigo syringe pain medication Infant acetaminophen liquid recalled due to potential defect with oral syringe Eighteen batches of Perrigo acetaminophen infant suspension liquid marked with various store brand names including Kroger and Babies R Us are being recalled because of a potential defect with the co-packaged oral syringe.

The affected medicines include the 160 mg/5 mL sold in 2 oz. and 4 oz. bottles with syringes in the box, and were distributed nationally to retail stores. The packages might contain an oral dosing syringe without dose markings. 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 the labeled use instructions.

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

“There are no issues or concerns with respect to the safety or efficacy of the product, only the potential that the oral dosing device in a relatively small number of packages could be unmarked,” Perrigo’s Chairman, President and CEO Joseph C. Papa stated in a release. “While we cannot be certain that any of these unmarked dosing devices were released into our customers’ supply chains, taking this action is the right thing to do.”

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 acetaminophen product is sold over-the-counter and 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.

Affected products include the brand names Babies R Us, Care One, Equaline, Equate, Harmon Face Values, Health Mart, Healthy Accents, HEB, Kroger, Leader Drug, Meijer, Publix, Rite Aid, Topcare, Up & Up, and Walgreens.

Consumers with this medicine with an oral dosing device that does not have dose markings 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 health care provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.

Source: FDA