The National Administration of Drugs, Food and Medical Technology (Anmat) requested the withdrawal from the market of a batch of paracetamol of a certain brand because the product did not pass hardness and friability tests, which was evidenced with broken tablets inside the alveoli of the blister.
This medication is used as an analgesic and antipyretic, and is indicated for the symptomatic relief of mild to moderate pain and feverish conditions.
It’s about a batch of Rofita – Paracetamol 500mg, hospital package containing 500 tablets, Primary packaging batch (blister): A71638 – Secondary packaging batch: 1A71638 – Expiration: 03/24, Certificate No. 50,576.
“The measure was taken after results were obtained out of specification for hardness and friability tests, showing broken tablets inside the blister alveoli”, reported from ANMAT.
And they added that the agency “is monitoring the withdrawal from the market and It is recommended to refrain from using the mentioned lot”.