The Chief Pharmaceutical Inspector issued a decision to withdraw an antibacterial drug from the market and introduce it to the Polish market. Decisions are immediately enforceable.
It is a drug called Linezolid – it is a prescription antibiotic. The drug has bactericidal, bacteriostatic and antibacterial effects. The Chief Sanitary Inspector issued two decisions regarding the preparation: one to withdraw specific batches of the drug from the market, the other to ban its introduction to the market. The reason is a quality defect of Linezolid.
Linezolid – GIF decision details
GIF provided details of medicines with quality defects in its announcements. Both decisions concern the same series of Linezolid and both are immediately enforceable. Details of the drug covered by the GIF decision:
Linezolid Polpharma (Linezolidum),
600 mg coated tablets, pack of 10 tablets,
GITN 05909991242718 for the following series:
batch number: 10421, expiry date: 30/04/2024,
batch number: 10421A, expiration date: 30/04/2024,
responsible entity: Zakłady Farmaceutyczne POLPHARMA SA based in Starogard Gdański.
Why was Linezolid withdrawn?
The representative of the responsible entity informed GIF about the drug’s defect. The company itself detected the irregularity as part of its ongoing drug stability testing program and the company itself recommended to GIF that the batch of Linezolid be withdrawn.
“In the case in question, the quality defect (…) consisted in failure to meet the quality requirements contained in the product specification for the parameter release after 30 minutes. This defect was assessed by the reporting MAH as causing a real risk of negative impact on the therapeutic properties of the medicinal product. The Chief Pharmaceutical Inspector accepted the findings of the MAH and based on them concluded that the abnormal release of the active substance of the medicinal product to an extent that may affect the therapeutic properties of this product constitutes a real threat to patients’ health due to the potential lack of effectiveness,” the GIF justified its decision. .