Mélanie Gomez with AFP // Photo credit: HOUIN / BSIP / BSIP via AFP
The German pharmaceutical laboratory Bayer said Thursday that it was recalling a batch of its plant-based drug Euphytose to promote sleep. A recall in agreement with the National Medicines Safety Agency and which follows the discovery of a Phenergan 25 mg tablet, which contains a neuroleptic, in a tube.
The German pharmaceutical laboratory Bayer said Thursday it was recalling a batch of its drug Euphytose, based on plants to promote sleep, after the discovery of an antihistamine inside a box, an isolated case in France.
A neuroleptic discovered in a tube of Euphytose
The Bayer HealthCare laboratory is proceeding, “in agreement” with the National Medicines Safety Agency (ANSM), “to recall lot SX2298 of the specialty Euphytose, in coated tablet (box of 180)”, indicated the Health division general public of the group which markets the product. This recall, which was initiated Wednesday afternoon, “follows the discovery of a blue tablet of the specialty Phenergan 25 mg” in a tube of Euphytose from this batch, which includes approximately 16,000 plastic bottles each containing 180 tablets, specifies the company.
This blue tablet is “smaller in size than the Euphytose tablets” which are brown in color, describes the group. It is manufactured by a subcontractor in France on the same site as Euphytose. “Patients holding a box of 180 Euphytose tablets from the lot affected by the recall must no longer take these tablets and must return the box(es) to the pharmacy for an exchange,” asks Bayer.
Phenergan, which contains a neuroleptic with antihistamine properties, is indicated in adults in cases of occasional insomnia, during travel for example. “The risk for patients who take Phenergan instead of Euphytose is increased drowsiness,” according to the ANSM. However, no reports of adverse effects linked to this problem have been reported to the laboratory to date, continues the drug watchdog, who emphasizes that “this packaging error has only been reported for a single tube of Euphytose” .
The batch concerned has been distributed only in mainland France since October 2023 and in Guadeloupe since the beginning of February 2024, underlines the ANSM.