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Quality Concerns Trigger Drug Recall

• Two batches of the oncology drug VAMFOLI have been recalled across Poland due to visible foreign particles found in the vials.
• The affected batches are BLPI2421YD (expiry October 2026) and BLPI2511YC (expiry February 2027).
• The initial detection of the foreign matter was made by staff at the Military Institute of Medicine in Warsaw.
• Authorities warn that the particles could lead to unpredictable and adverse health outcomes if they enter a patient's bloodstream.

The Chief Pharmaceutical Inspector initiated the recall of two specific production runs of the cancer treatment drug VAMFOLI. The decision followed the detection of visible, floating foreign material within the vials, indicating a potential quality defect. Authorities warn that if these particles enter a patient's bloodstream, the health consequences could be unpredictable and adverse. The recall required an immediate halt to sales of thousands of packages nationwide (GIF wydał ważne ostrzeżenie. W leku wykryto ciała obce. "Rygor natychmiastowej wykonalności" – biznesinfo.pl). Personnel at the Military Institute of Medicine in Warsaw first observed the suspended residues in the vials and promptly notified the regulatory bodies. Subsequent inspections at a pharmaceutical warehouse confirmed the issue, revealing foreign particles of different shapes in 72 randomly examined packages.

Affected Product and Distribution Details

The medication in question is VAMFOLI 50MG/5ML, which contains Leucovorin Calcium and is supplied as a solution for injection in a 50 mg/5 ml, single-vial format. The recall affects two specific production batches. The first batch, series BLPI2421YD, has an expiration date of October 2026. The second batch, series BLPI2511YC, has an expiration date extending to February 2027. The product originates from the Indian manufacturer Vama Lifecare Pvt Ltd and was distributed by the Warsaw-based company MEDYK-LEK Panek.

Regulatory Action and Safety Measures

GIF mandated the removal of these two series from the market throughout Poland. The affected products are being quarantined immediately to prevent further distribution. The regulatory action is linked to a permit issued by the Minister of Health on February 14, 2025, under number DOP/00153/25, concerning the first identified series. Consumers and pharmacies should take necessary steps regarding any remaining vials.