Africa-Press – Mozambique. The National Medicines Regulatory Authority (ANARME, IP) has ordered the immediate suspension of the sale and the removal from national territory of batches of pharmaceutical products manufactured by Bharat Parenterals Limited – India.
The affected batches are: batches T3236 and T4281 of Aluminium Hydroxide 500 mg tablets; all batches of Phenoxymethylpenicillin 500 mg tablets; batch T4130 of Salbutamol 2 mg tablets; batch T3362 of Paracetamol 500 mg tablets; batches DS4012 and DS4011 of Trimethoprim + Sulfamethoxazole 40+200/5ml suspension; and batch T4364 of Azithromycin 500 mg tablets.
According to an ANARME statement, these products are indicated for the treatment of various clinical conditions, depending on each active substance, including antimicrobial, anti-inflammatory, bronchodilator, and analgesic therapies according to the formulation.
This measure was taken after observing that the banned batches showed changes in their organoleptic and physicochemical characteristics — notably colour, odour, presence of particles, lumps, or stains — which constitute quality deviations from the specifications established in the monographs.
Accordingly, ANARME has ordered that entities holding the affected batches must cease selling, dispensing, or administering them, and must immediately return the products to their suppliers.
Meanwhile, for patients currently using the products under alert, healthcare professionals should replace them with alternatives from other manufacturers as soon as possible.
The temporary suspension on purchasing products from Bharat Parenterals Limited – India remains in effect until the investigation is concluded. Afri-Farmácia must begin the immediate nationwide collection of the affected products, in accordance with existing legislation.
