The CFederal omission for Protection against Health Risks (Cofepris) has ordered the immediate withdrawal of the anesthetic Vitalis SILTAFEL® (Propofol) Emulsion 200 mg/20 mL injection, with lot number PR23J01, after identifying microbiological contamination in the product.
This announcement follows a health alert initial issued on March 15, 2024, where the immobilization and preventive suspension of the use of this medication was requested.
The problem was detected during health surveillance inspections in a private hospital in Mexico City, where the use of the contaminated lotwhose expiration date is marked for October 26.
In response, the distribution company, PHARMASERVICE, SA de CV, has begun the process of withdrawing this specific batch of the anesthetic from the market..
Cofepris has issued a series of recommendations for health establishments and professionals who may have units of this product in their possession.
You are urged to immediately return the product to PHARMASERVICE and retain evidence of the return. In addition, the use and administration of the product with lot PR23J01 should be immediately suspended due to the risk it represents to health.
Contacts to coordinate the collection of the product include the emails [email protected] and [email protected], as well as the telephone numbers 55 5884 2251 and 44 2312 2711.
Cofepris also encourages reporting any adverse reaction or discomfort associated with the use of this anesthetic through the online link or to the email [email protected].
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