This Thursday, the National Agency for the Safety of Medicines and Health Products (ANSM) announced the recall of two batches of BCG-Medac, a drug prescribed for several types of bladder cancer, due to a defect in sealing spotted on certain bottles.
“We have been informed by the Medac SAS laboratory of the identification of a leak-tightness defect in the vials present in certain boxes of batches C230298A and C230298D of the BCG-Medac specialty,” the press release specifies.
Only “a few rare cases of leaks from bottle caps” would be affected.
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“Hospital pharmacies that have issued this product must contact the patients concerned in order to exchange boxes with a compliant batch,” explains the ANSM.
Patients who have an affected box at home can also go to the pharmacy where the medicine was purchased to have it exchanged.
The batch number is on the medicine box.
No impact on coverage of needs
This flaw would be due to “an adjustment fault during a packaging step, which could have impacted a small number of bottles”.
“Medac has implemented corrective measures to ensure good packaging of the batches produced,” affirms the ANSM.
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According to the laboratory, this recall does not impact the coverage of patients' needs which will remain assured.