The body also suspended batch 8891/25 of Water for Infusion SOL INFUS IV CX 35 BOLS PVC SIST, from Indústria Farmacêutica S/A
The National Health Surveillance Agency (Anvisa) determined this Tuesday (02) the suspension of the sale, distribution and use of batches of medications for blood pressure control and cancer. When contacted, the manufacturers did not comment. The space remains open for manifestation.
Mesilato de eribulina
According to the agency, one of the bans involves batch 148386 of the drug Halaven (eribulin mesylate) – 0,5mg/ml SOL INJ CT FA VD TRANS X 2ML.
The product, manufactured by United Medical Ltd, It is used in the treatment of breast cancer. “The company has already communicated the voluntary recall of the medicine due to quality deviation related to the content of the active ingredient below the approved specification,” said Anvisa. The measure prohibits the marketing, distribution and use of the product.
Enalapril maleate
Lots 0062/26M, 0063/26M, 0064/26M, 0088/26M, 0089/26M, 0358/26M, 0415/26M, 0506/26M and 0507/26M of the drug enalapril maleate – 20 MG WITH CT BL AL PLAS TRANS 500 (EMB HOSP), used to control blood pressure, were also suspended by Anvisa.
According to the manufacturer, Hipolabor Farmacêutica Ltda, there was a quality deviation due to textual inconsistency in the secondary packaging. The packages mistakenly indicate “10 mg” in the composition description.
“In addition to suspending the sale of the medicine, the measure prohibits the marketing, distribution and use of the product”, states Anvisa.
Water for injection
Anvisa also suspended batch 8891/25 of Water for Infusion SOL INFUS IV CX 35 BOLS PVC SIST, from Indústria Farmacêutica S/A.
According to the agency, a report issued by the Adolfo Lutz Institute showed unsatisfactory results in the test on the product’s appearance. “The measure provides for the recall of the product, in addition to prohibiting its sale, distribution and use.”
Pequi oil capsules
A The Agency’s resolution also determined the seizure of all batches of the medicine capsules of pequi oil produced by R TK Indústria de Cosméticos e Alimentos Naturais Ltda.
The product has no registration, notification or registration with Anvisa and is manufactured by a company without operating authorization. “The measure also prevents the marketing, distribution, manufacturing, advertising and use of the medicine,” said Anvisa
