Losartan drug recalled for labeling error, ANSM warns

Losartan drug recalled for labeling error ANSM warns

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    Dr. Yves Dour (pharmacist)

    The National Medicines Safety Agency (ANSM) has given the alert: batch LC67239 of the drug Losartan should not be consumed, due to a labeling error. The boxes of the affected lot have since been recalled across France.

    Batch LC67239 of the drug Losartan/hydrochlorothiazide BGR 100 mg/25 mg was recalled by the Biogaran laboratory in a press release from the ANSM on June 1. The cause ? A printing error on blisters, these plastic shells under which certain drugs are placed, inside cardboard boxes. The drugs concerned were dispensed between May 12 and May 25, 2022.

    The printing error in question

    On the blisters it is written “Atorvastatin Cristers Pharma 40mg film-coated tablet”a drug used to lower cholesterol levels, instead of “Losartan/hydrochlorothiazide BGR 100 mg/25 mg film-coated tablets” (box of 30 tablets).

    Losartan, on the other hand, is an antihypertensive, used in adults and children over the age of six to lower mild to moderate forms of hypertension (raised blood pressure).

    The ANSM made a point of specifying that in spite of this printing error, “the tablets in the blister packs are indeed Losartan / hydrochlorothiazide BGR 100mg/25mg tablets”. Only batch LC67239 is affected by this defect, and the Biogaran laboratory specifies “that no case of pharmacovigilance related to the quality defect has been reported to date”.

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    ANSM recommendations

    If you have boxes of Losartan marked “lot LC67239”bring them back to the pharmacy. “You will be exchanged for an identical box from another batch”guarantees the ANSM.

    If you’ve taken pills from this batch before, don’t worry. “There is no risk to your health”reassures the ANSM, especially since it is indeed tablets of Losartan.

    “As long as there is no manufacturing error of the drug inside the box, there is no risk of use, insofar as one is well with the good drug”adds Dr. Yves Dour, pharmacist.

    Pharmacists, like Dr. Yves Dour, are asked to contact patients to whom they have given drugs from the batch in question, between May 12 and 25. Do not hesitate to “reassure that the tablets contained in the blister packs are compliant despite the printing error” and of “exchange with a box from another batch”says the Medicines Agency.

    To avoid confusion, “it was better to recall the batches”, explains Dr. Yves Dour. According to the pharmacist, “this type of technical error – i.e. labeling – happens very infrequently”but safety on the drug takes precedence above all in France, where “the drug manufacturing and distribution chain is highly standardized and standardized”.

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