The national medical authority (Infarmed) ordered, this Friday, the withdrawal from the market of three batches of shampoo for the treatment of lice “Paranix Extra Forte” for being in an “irregular situation”.
Infarmed said in a statement published on its website, that it identified, as part of an inspection, the availability in the national market of three batches of this medical device, from the manufacturer Omega Pharma International NV, distributed by the company Perrigo Portugal, Lda. whose expiration date featured a self-adhesive label that covered and changed the expiration date printed on the product label.
Although the manufacturer has presented technical-scientific evidence that supports the new longer shelf life, the batches in question are in an irregular situation, since the information on the shelf life must be unequivocal and indelible as it is a critical aspect from the start. point of view of the vision of safety and performance for the user”, says the National Authority for Medicines and Health Products.
In this sense, the company Perrigo Portugal immediately and voluntarily suspended the sale of the product units, of the affected batches, which were still in stock.
Thus, Infarmed orders the “immediate suspension” of the marketing of lots D0250121/R, D0250131/R and L9251221/R of Paranix Extra Strong Shampoo that are still in “stock”.
“Products that are already in the rest of the marketing circuit can be sold and used,” underlines the medicine authority.
Source: Observadora
