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In a statement, the National Medicines Authority (Infarmed) states that the company “Merck Sharp & Dohme BV” will proceed to the voluntary collection of the drug Zerbaxa 1g / 0.5g powder for concentrate for solution for infusion, with registration number 5665005 of lots “T003099”, “T003958” and “T005031”, all with an expiration date on February 28, 2022.
“This collection is done as a precaution, after the detection of out-of-specification results in the sterility tests of batches of the drug manufactured with the same equipment as the batches mentioned above,” says Infarmed.
Faced with this situation, the drug authority determined “the immediate suspension of the marketing of these batches” and urges the entities that have this batch of drug in ‘stock’ not to sell, dispense or administer it, and must return it.
According to the drug information leaflet, Zerbaxa is used in adults to treat complicated infections in the abdomen, kidneys, and urinary system.
It is also indicated for the treatment of “intra-hospital pneumonia (PAH), including ventilator-associated pneumonia (VAP).”
