The laboratory EG Labo has withdrawn several batches of the antihypertensive amlodipine. In fact, the information was reported in a statement from the National Medicines Safety Agency (ANSM). We note that this decision was made following an error. This is the inversion of the container between 2 doses. The error occurred during the packaging of batch A53014 of Amlodipine EG 5 mg.
More specifically, Amlodipine EG 5 mg wafers were packaged in Amlodipine EG 10 mg boxes. According to the press release of the National Agency for the Safety of Medicines (ANSM), all boxes of batches A53014 of amlodipine EG 5 and 10 mg are being recalled because the data matrix code printed on the box of amlodipine 10 mg refers to amlodipine EG 5 mg.
The risk posed by this error is the ineffectiveness of the product in the treatment according to the warnings of the National Medicines Safety Agency. Therefore, the product would be underdosed. The appeal of the French agency is addressed to both pharmacists and patients who use this product. Pharmacists are therefore invited to contact patients to whom they have dispensed Amlodipine from these batches so that they can carry out verification.
Please note that the products in question have been in circulation since 21 June 2023. The expiry date for these products is February 2028. Amlodipine EG 5mg, capsule – box of 30, lot A53014 and Amlodipine EG 10 mg, capsule – box of 30, batch A53014 will be discontinued on the same date.