2024-02-22 16:34:00
The German pharmaceutical laboratory Bayer said on Thursday it was recalling a batch of its drug Euphytose, based on plants to promote sleep, following the discovery of an antihistamine inside a box, an isolated case in France.
The Bayer HealthCare laboratory carries out, “in agreement” with the National Medicines Safety Agency (ANSM), “recall of batch SX2298 of the specialty Euphytose, in coated tablet (box of 180)”indicated the Consumer Health division of the group which markets the product.
This recall, which was initiated Wednesday followingnoon, “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, the company specifies.
This blue tablet is “smaller in size than 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.
The lot concerned has been sold in France and Guadeloupe since October 2023
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.
How do you know if your box is affected and how to proceed?
How do I know if my box of Euphytose comes from lot SX2298?
The batch number is on the box of your medicine. If a reference other than SX2298 is written on your box, you are not affected by the recall.
I am concerned, what should I do?
Return your box to the pharmacy. Your pharmacist will check your box and, if necessary, issue you with a new box from a compliant batch.
If you think you have taken Phenergan instead of Euphytose, ask your pharmacist or doctor for advice, especially if you are breastfeeding (risk of newborn sleep apnea) or if you are epileptic (risk of exacerbation of seizures). Do not drive for 24 hours following taking it.
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