The Main Pharmaceutical Inspector has suspended the drug used in the treatment of, inter alia, endocrine disorders or RA. What was the reason for the decision?
The Main Pharmaceutical Inspector has suspended the following medicinal product in trade and use throughout the country:
Encorton (Prednisonum) 10 mg, 20 tablets per vial, lot number: 41546026, expiration date: 06.2018
Encorton (Prednisonum) 20 mg, 20 tablets per vial, lot number: 41546026, expiration date: 06.2018
The entity responsible is Pabianickie Zakłady Farmaceutyczne Polfa SA
The decision was made immediately enforceable.
The reason for the decision was the suspicion that the quality requirements of the given batches of the medicinal product were not met. The reason for the reports was the discrepancy in the dose range on the product packaging. The outer packaging indicated a dose of 10 mg and the immediate packaging indicated a dose of 20 mg.
Indications:
Endocrine disorders (inflammation of the thyroid gland); rheumatic diseases: psoriatic arthritis, rheumatoid arthritis, the initial period of rheumatic disease, acute bursitis, acute inflammatory bursitis, acute gouty arthritis; collagenosis – systemic lupus, rheumatoid arthritis; skin diseases – pemphigus, severe erythema multiforme, exfoliative dermatitis, severe psoriasis; allergic diseases – severe forms: asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions; acute and chronic allergic and inflammatory processes of a severe degree affecting the eyeball; chronic diseases of the gastrointestinal tract – Leśniowski and Crohn’s disease, autoimmune hepatitis, respiratory system diseases – exacerbations of chronic bronchitis, aspiration pneumonia, tuberculosis; hematological diseases – anemia, thrombocytopenia; cancers.