Mozambique’s National Medicines Regulatory Authority (ANARME) has ordered the immediate suspension of sale and withdrawal from the national market of methyldopa 250mg film-coated tablets manufactured by Remedica Ltd of Limassol, Cyprus, after black spots were observed on the surface of tablets from several batches.
Facilities holding the product must not sell, dispense or administer it and must return stock to their supplying units.
ANARME attributed the decision to changes in the tablets’ organoleptic characteristics — the black spots — placing the product outside the specifications of the relevant British Pharmacopoeia 2026 monograph.
The alert lists the product’s indications as hypertension in pregnancy; mild to moderate hypertension not controlled by thiazide diuretics alone; and as an alternative to reserpine where that agent is contraindicated or inadequate.
