Un recall of batch JBM2300810F (expiration 07/2025) of the specialty ATORVASTATIN ARROW GENERIQUES 10 mg film-coated tablet and vial (flacon de 30, code CIP 3400930035320) is organized in pharmacies, in health establishments and with patients [1, 2].
This is a precautionary measure following the discovery of gliclazide 30 tablet mg modified release in one vial of this lot. Both tablets (atorvastatin and gliclazide) are white in color, but their shape and engraving are different:
- ATORVASTATIN 10 mg white oval tablet measuring 9.70 mm x 5.10 mm, engraved AS on one side and 10 on the other;
- GLICLAZIDE 30 mg oblong white tablet measuring 10 x 4.5 mm, biconvex, G30 engraving on one side only.
To date, this packaging error has only been reported for a single vial of ATORVASTATIN ARROW GENERIQUES 10 mg.
Boxes of ATORVASTATIN ARROW GENERICS 10 mg film-coated tablet in blister pack (CIP 3400930177914) are not affected by this alert.
The laboratory has ruled out a risk of supply shortage of atorvastatin linked to this recall.
A hypoglycemic agent in a bottle of lipid-lowering tablets
Atorvastatin is used in the treatment of hypercholesterolemia while gliclazide is a medication indicated in diabetes (type 2), to reduce blood sugar (sulphonylurea).
The risk for patients taking gliclazide instead of atorvastatin is hypoglycemia.
No pharmacovigilance cases related to quality defects have been reported to the laboratory to date.
Check the batch number and ask the pharmacist for advice
The batch affected by the recall was distributed from February 5, 2024 in pharmacies and hospitals.
Pharmacists are asked to:
- remove from the dispensing circuit the boxes of lot JBM2300810F (expiration 07/2025) of the specialty ATORVASTATIN ARROW GENERIQUES 10 mg;
- contact patients to whom ATORVASTATIN ARROW GENERIQUES 10 mg film-coated tablet has been dispensed.
After checking the batch number, patients holding a box of the batch concerned must return it to the pharmacy for exchange with a new compliant bottle. Patients should be reminded not to stop or change their treatment without medical advice.
Patients who experience symptoms suggestive of hypoglycemia (sweating, paleness, abnormal feelings of hunger, nausea, tremor, dizziness, headache, dizziness) after taking the usual cholesterol treatment should contact their doctor.
