The Chief Pharmaceutical Inspector has ordered an immediate nationwide recall of several batches of the throat spray Envil, citing safety and efficacy concerns following irregular ethanol content discovered during stability testing.
Immediate Market Recall
The Chief Pharmaceutical Inspector (GIF) has issued an immediate nationwide recall for the popular throat spray Envil. The decision affects six specific batches of the 30 ml oral aerosol product manufactured by Aflofarm Farmacja Polska, which is used to treat upper respiratory tract infections and sore throats.
The recall carries an immediate enforcement order, requiring all pharmacies to pull the affected batches from their shelves and prohibiting their further sale to the public. The decision was prompted by long-term stability testing that revealed ethanol levels failing to meet the product’s established quality requirements.
Quality Standards and Patient Safety
The issue is strictly a matter of quality parameters established during the product’s registration rather than a case of counterfeit goods or contamination. GIF clarified that ethanol content is vital for the product’s durability and overall performance.
Because the laboratory results for ethanol content fell outside of acceptable norms, the inspectorate can no longer guarantee the medication’s safety or efficacy. A product may appear entirely normal, smelling and looking as expected, while still failing to meet the necessary quality standards.
Guidance for Consumers
Patients currently in possession of Envil throat spray are urged to check the batch number printed on the packaging or bottle. If the product matches the batches identified by the GIF, it should not be used.
The manufacturer, Aflofarm, had already voluntarily suspended the sale and production of the affected batches prior to the official regulatory decision while an investigation was ongoing. The company previously assessed the health risk to patients as low, despite the official withdrawal.