A small number of packages might contain an oral dosing syringe without the dose markings
Perrigo, a US manufacturer of over-the-counter (OTC) and generics medicines, has initiated a voluntary, nationwide product recall of 18 batches of its acetaminophen infant suspension liquid, 160mg/5mL, sold in 2oz and 4oz bottles with syringes in a box.
Full details of the labels and batch numbers are given on the Perrigo website (see below for link).
The firm says it is recalling the OTC product because of the 'remote potential' that a small number of packages might contain an oral dosing syringe without dose markings and infants might therefore mistakenly be given too high a dose.
The correct syringe should have a white or yellow plunger with specific dose markings for 1.25mL, 2.5mL, 3.75mL, and 5mL. If the product's syringe has these dose markings, consumers can continue to use the product while following labelled use instructions.
Perrigo's Chairman, President and CEO Joseph Papa emhasised that 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'.
'We are taking this measure to maintain the highest possible product quality standards for our retail customers and consumers,' said Papa.
'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 firm says it has not received any reports or complaints related to this defect, nor has it found any product with missing dose markings on re-examination of the 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. The recalled products are sold by distributors nationwide and distributed through retail stores.