Two batches of Upfen 200mg recalled following a dosage error for children

A dosage error that could lead to an overdose has been identified in the instructions for certain boxes of Upfen 200mg, a drug containing ibuprofen, indicated for pain, fever and available without a prescription. This error specifically concerns children between 20 and 30 kg: the maximum daily dose indicated in mg (1200 mg) corresponds in fact to double what is normally authorized, namely 600 mg.

“This error could lead to a risk of overdose, the UPSA laboratory identified the offending batches and proceeded to a recall of the batches of the specialty UPFEN 200mg (film-coated tablet), specifies the ANSM in a statement. To date, there have been no reports of cases of overdose in connection with this error in the package leaflet.

Affected batches:

• UPFEN 200 mg, film-coated tablets (Box of 20 tablets) – CIP 34009 332 159 0 3
  • Batch T3829 expiry date 05.2020
  • Lot T9703 expiry date 05.2021

A poster to be displayed in pharmacies for the attention of the public will soon be distributed to pharmacists through wholesalers. This poster asks patients to return the boxes of the two batches concerned in their possession to the pharmacy. For any question of medical information, you can contact 0 800 502 045 (Free service and call) or 03.21.18.22.70. “The quality of the tablet is not impacted”, nevertheless specifies the ANSM. In the leaflet in question, “the maximum dose expressed in number of tablets is compliant, namely 3 tablets per day”.

Dosage reminder:

In children, the usual dosage is 20 to 30 mg/kg/day in 3 doses per day (without exceeding 30 mg/kg/day).

• In children from 20 to 30 kg (approximately 6 to 11 years): 1 tablet (200 mg), to be renewed if necessary after 6 hours. In any case, do not exceed 3 tablets per day (600 mg).
• In adults and children over 30 kg (approximately 11-12 years): 1 to 2 tablets (200 mg to 400 mg), to be renewed if necessary after 6 hours.