16,000 boxes of anti-stress drug recalled after another drug found in tube

The National Medicines Safety Agency warns of the risk of “increased drowsiness”, even sleep apnea in newborns and people with epilepsy.

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A box of the medicine Euphytose.  Illustrative image.  (HOUIN / BSIP)

16,000 boxes of Euphytose, a drug intended to relieve stress, were recalled after the discovery of another drug in a tube, France Bleu learned Thursday February 22 from the National Medicines Safety Agency (ANSM) .

These are Phenergan tablets, an antihistamine, which slipped into certain tubes, according to the ANSM. Both tablets are manufactured on the same Bayer laboratory site. The laboratory reported the discovery of a blue tablet of the specialty Phenergan 25 mg (promethazine) in a tube of Euphytose (brown tablets) of 180 tablets.

Return the affected batch to the pharmacy

“We were alerted to the discovery by a patient”, explains the ANSM. The Agency has not received any other reports at this time. “Given the information available at this stage, it appears that this defect is an isolated case.” But as a precautionary measure, the Bayer laboratory and the National Medicines Safety Agency are recalling the entire batch of Euphytose. The batch affected by the recall is SX2298 with an expiry date of 03/2025. Patients who have a box of the affected lot at home are invited to return it to the pharmacy for replacement.

The Agency warns that Phenergan can cause “increased sleepiness”. If taking Phenergan instead of Euphytose, you should seek advice from your pharmacist or doctor, “especially if you are breastfeeding”specifies the ANSM, because this can lead to “risk of sleep apnea in newborns”Or “if you are epileptic (risk of exacerbation of seizures)”. The Agency finally advises not to drive for 24 hours after “the supposed catch”.


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