- Since 2022, the product lost its sanitary registration because irregularities were identified and it does not comply with current legislation.
- Cofepris recommends suspending its application immediately if it is being supplied.
- Pharmacies and distributors that continue to sell this brand of Paracetamol will be fined and may even receive a total suspension of work.
Medicines are one of the most important inventions of the contemporary era. Its correct use helps prevent millions of deaths each year. At the same time, it is also one of the most closely watched industries due to its direct impact on health. Therefore you should review the following information about a Paracetamol brand because it could put your patients at risk.
After a process of analytical investigation, the Federal Commission for the Protection against Sanitary Risks (Cofepris) posted an alert. The reason is the revocation of the Sanitary Registration of the product Axapara (paracetamol injectable solution). According to what was reported, since 2022 his license was revoked. Sanitary Registry No. 104M2019 SSA IV.
Characteristics of the Paracetamol brand that should not be consumed
In this regard, this health authority identified irregularities in parts of the product. Some of the main ones are: color change, presence of particles on the lid, re-lid and inside the product.
According to the analytical results carried out, it was concluded that it is out of specification for the sterility and hermeticity tests, indicative of failures in the container-closure system (non-hermetic product).
While additionally, the characteristics of the primary packaging do not correspond to those that were evaluated and granted the sanitary registry. Therefore, said modifications do not guarantee the characteristics of identity, purity, safety, efficacy and quality required for its use, which represents a health risk if supplied.
Therefore, Cofepris recommends:
- No batch of the Axapara product (paracetamol injectable solution 100 mg/100 ml) should be marketed, distributed, or supplied to patients.
- If you are using this product, stop it and contact a health professional immediately.
- While if this product is identified for sale or there is promotion of the aforementioned medicine, it is pertinent to file the corresponding health complaint through the Cofepris website.
Finally, it is reported that since these are products that do not comply with current health legislation, they should not be marketed by any means or distributed by parcel services, national and/or international courier services. Nor should they be advertised on websites or on social network pages or of any kind within the national territory.
Support is requested from pharmacies and distributors so that, if the aforementioned product is in stock, it can be immobilized and the health complaint made through this web page.
Finally Cofepris said that distributors who violate this provision will be subject to the sanctions stipulated in current legislation.. This regulatory authority continues to carry out health surveillance actions to prevent products, companies or establishments from failing to comply with health legislation and representing a risk to the health of the population.
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