One batch of cholesterol-lowering medication recalled because it contains a diabetes tablet

The ANSM was informed by the Arrow laboratory of the discovery of a Gliclazide 30 mg tablet with modified release (hypoglycemic) in a bottle of tablets from the lot JBM2300810F of atorvastatin Arrow generic 10 mg, film-coated tablet (lipid-lowering).

What are the risks?

All vials of generic atorvastatin Arrow 10 mg, film-coated tablet from lot JBM2300810F are therefore recalled. Patients who have a bottle from this lot at home are invited to return it to the pharmacy for replacement.

In a bottle from this batch, a tablet of Gliclazide, an oral antidiabetic used to treat type 2 diabetes, was found. This mixture poses a serious risk: Gliclazide can cause hypoglycemia (dangerous drop in blood sugar levels) in people without diabetes. No pharmacovigilance cases related to quality defects have been reported to the laboratory to date.

Who is affected by this recall?

Atorvastatin 10 mg is a medicine used in the treatment of long-term cholesterol. Gliclazide is indicated for the treatment of non-insulin-dependent type 2 diabetes. Both tablets are white in color but their shape and engraving are different.

This packaging error has only been reported, to date, for a single bottle of generic atorvastatin 10 mg Arrow (30 bulk tablets) and does not concern boxes of atorvastatin in blister packs.

The ANSM reminds patients to check their bottles and immediately return any suspicious product to the pharmacy. Those who experience unusual symptoms should consult their doctor immediately. To find out if you have a bottle that comes from the lot, JBM2300810F, look at the reference written on it. If a reference other than JBM2300810F is listed, you are not affected by the recall.

Patient advice

If the reference JBM2300810F is listed, do not stop or change your treatment without medical advice and return your bottle to the pharmacy.

Your pharmacist will check your bottle and, if necessary, will issue you with a new box from a compliant batch.

If after taking your usual atorvastatin 10 mg treatment you experience symptoms suggestive of hypoglycemia such as sweating, paleness, abnormal feeling of hunger, nausea, tremors, dizziness, headache, dizziness, contact your doctor.

Advice for pharmacists

Pharmacies were asked to inform affected patients and offer them an exchange of the product or a refund. The ANSM also asks doctors to remain vigilant in the face of possible cases of unexplained hypoglycemia in their patients.

This type of incident highlights the crucial importance of rigorous controls in the manufacturing of medicines. The vigilance of patients and professionals is essential to prevent any major health risk.