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In a press release, the National Medicines Safety Agency explains that it is recalling all boxes of Alprazolam (Xanax®), used in the treatment of anxiety, for the risk of overdose.
Take care if you are takingAlprazolam. In a press release published on October 19, the National Agency for the Safety of Medicines and Health Products (ANSM) and the KRKA France laboratory announce that they are proceeding with the recall of all lots currently on the market of this benzodiazepine, better known under the name Xanax®, because of an error in the instructions.
Xanax® recall: “no case of pharmacovigilance” reported
The error is “at the maximum recommended dose for the treatment of anxiety”:“Indeed, it should read “Recommended dose: your doctor may increase your dose if necessary, up to the maximum dose of 4 mg per day, divided into divided doses during the day”, not “4 g per day””, Warns the ANSM. According to the KRKA laboratory, “no case of pharmacovigilance related to this quality defect was reported on the date of the recall”.
Pharmacists are requested “to contact, by all the means at their disposal, the patients likely to have and / or to have used the specialties concerned by this recall and to proceed to an exchange with a box of another equivalent generic specialty of their choice”.
Xanax® recall: affected lots
These are more precisely the specialties Alprazolam HCS 0.25 mg, tablet, box of 30 (CIP: 34009 301 664 2 0) and Alprazolam HCS 0.5 mg, tablet, box of 30 (CIP: 34009 301 667 0 3 ) and the following lots:
Alprazolam HCS 0.25 mg, tablet
- Lot D86731 – EXP 02/2022
- Lot D90677 – EXP 02/2022
- Lot D93064 – EXP 05/2022
- Lot D97349 – EXP 01/2023
- Lot DA1451 – EXP 05/2023
Alprazolam HCS 0.5 mg, tablet
- Lot D91255 – EXP 02/2022
- Lot D93149 – EXP 08/2022
- Lot D95574 – EXP 09/2022
- Lot D97590 – EXP 01/2023
- Lot DA1931 – EXP 05/2023
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