Pfizer recalls children’s painkiller after label sparks overdose fears

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(Image: Getty/Mayakova) (Getty Images/iStockphoto)

Pfizer announced the voluntary recall of a batch of Advil after overdose fears arose due to an error on the label.

The recall of one lot of children’s Advil, which contained 28,000 units, was instigated after the label mistakenly advised dosage in millilitres whilst the dosage cap metered doses in teaspoons (4.9 millilitres in the US).

As a result, there were fears that consumers could accidentally read the label without realising the discrepancy – with teaspoons containing five millilitres of medicine leading to concern that there was potential for overdosing.

Dangers associated with taking too much of the medication are for ibuprofen overdose; the press release outlining the issue noted that this could include: “nausea, vomiting, headache, drowsiness, blurred vision and dizziness”.

A spokesperson explained how the error had occurred, by outlining to us that: “Dosing units for the product was converted recently from US teaspoons to millilitres. The new dosage instructions on the label were in millilitres and the old dosing cup in US teaspoons was used in the affected lot.”

In order to prevent this from happening again, the spokesperson added that procedures had been put in place to ensure that label instructions were aligned with the correct dosing cup.

Pfizer, which counts the product as part of its Consumer Healthcare business, revealed that it had been alerted to the issue after customer complaints.

The company announced that it had notified wholesalers, distributors and retailers to arrange the return of the product, which had been circulated nationwide in the US.

The Advil product is part of a portfolio that Pfizer had spent the earlier part of this year trying to find a buyer for. Reckitt Benckiser was involved in discussions, but only held an interest in acquiring the painkiller and other selected products to add to its own consumer healthcare portfolio; however, Pfizer was uninterested in selling part of the portfolio.