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Following the discovery of an antihistamine in one of the boxes of Euphytose, a natural plant-based anti-stress, the German laboratory Bayer announced the recall of a complete batch.
It was the discovery of another drug in a box of Euphytose which prompted the Bayer laboratory to organize the recall of the batch.
A blue Phenergan tablet found in a box of Euphytose
Euphytose is a brown herbal anti-stress tablet that helps promote sleep. Nothing to do with Phenergan 25mg (promethazine), a blue antihistamine. However, one of these tablets ended up in a box of Euphytose. Following this discovery, the German laboratory Bayer announces the massive recall of a batch of Euphytose in France.
An exchange to be carried out in pharmacy, 16,000 boxes concerned
In agreement with the National Medicines Safety Agency (ANSM), Bayer is therefore proceeding “recall of batch SX2298 of the specialty Euphytose, in coated tablet (box of 180)”said the consumer health division of the pharmaceutical giant in a press release.
Bayer HealthCare therefore invites patients in possession of a box of 180 Euphytose tablets from the batch concerned to no longer take them. They are asked to return them to the pharmacy.to make an exchange”. The incriminated batch has been distributed only in mainland France since October 2023 and in Guadeloupe since the beginning of February 2024, underlines the ANSM.
An error on a single tube
Fortunately, no reports of adverse effects have been reported so far, reports the ANSM, which indicates that “This packaging error has only been reported for a single tube of Euphytose.”.
“The risk for patients taking Phenergan instead of Euphytose is increased drowsiness” explains the Medicines Agency. In fact, it contains a neuroleptic with antihistamine properties and it is prescribed for adults in cases of occasional insomnia. This is why the health authority recommends not driving for 24 hours after “the supposed intake”. And calls for advice from your pharmacist or doctor, “especially if you are breastfeeding” as this may result in “risk of sleep apnea in newborns“, or “if you are epileptic (risk of exacerbation of seizures)”.