ALLEGAN, Mich. — Perrigo on Friday 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 because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings.
“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," stated Joseph Papa, Perrigo president and CEO. "Out of an abundance of caution, we are taking this measure to maintain the highest possible product quality standards for our retail customers and consumers. 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.”
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, the private label manufacturer stated.
Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants, Perrigo noted.