Poland’s Main Pharmaceutical Inspectorate has immediately recalled two batches of Lorafen due to quality concerns affecting active ingredient release.
Why Did GIF Recall the Drug?
Tests revealed a quality risk to patients after long-term stability studies showed the degree of active substance release was below permissible minimums, not just individually but in average measurements.
Which Drug Was Recalled?
Withdrawn from circulation: Lorafen (lorazepam), 1 mg, coated tablets, packaging: 25 tablets. The manufacturer is Tarchomińskie Zakłady Farmaceutyczne “Polfa” SA.
Quality Defect in Lorafen: What Went Wrong
The problem occurred during production, not distribution. During one process, an intermediate product was overheated, affecting tablet properties. Only two batches from this specific production run were affected.
Patient Guidance: What to Do with Recalled Lorafen
The GIF decision primarily affects pharmacies and wholesalers. Patients should not discontinue treatment independently without consultation, especially since lorazepam affects the nervous system.
Immediate Enforcement: Why It’s Urgent
GIF classified this as immediate enforceability, meaning the drug must be removed from the market immediately. Pharmaceutical law leaves no room for interpretation—products not meeting quality requirements cannot be sold or used.
Are Other Batches at Risk?
The defect is limited to specific batches from one intermediate product batch. Other Lorafen batches and dosages remain under monitoring but have not been affected at this stage.