The Federal Commission for the Protection against Sanitary Risks (Cofepris) warned about the falsification and irregular marketing of two drugs used in the treatment of specific types of cancer. These are: Perjeta (pertuzumab) solution 420 mg/ 14 mL (30 mg/mL) and Tagrisso (osimertinib) 80 mg.
The detected lot numbers are: K8567H92 with expiration date SEP 22 (already expired), L3200A27 with expiration date 01NOV24, H0652H02 with expiration date JUN 25, H0639B03 with expiration date 24MAR25 and H0642B02 with expiration date 09APR25.
Through a statement, Cofepris reported that Productos Roche, holder of the Perjeta health registry, warned about the irregular marketing of products that present batch numbers with certificates analytical tests that were not issued or authorized by the company, as well as the existence of falsified batches.
For its part, AstraZeneca informed said health authority that lot number FJ0327 of Tagrisso (osimertinib) 80 mg tablets, with an expiration date of 06 2025, It does not correspond to any manufactured by them.
Furthermore, he added, in Mexico presentation in a bottle is not authorized, which makes its commercialization in the country an illegal activity.
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“Because of the above, and given that the manufacturing, transportation, storage and distribution conditions of these products are unknown, it is not possible to guarantee their safety, quality and effectiveness, which implies a risk to the health of those who consume them”said the agency.
Therefore, it was recommended that the population not acquire or consume Perjeta (pertuzumab) solution 420 mg/ 14 mL (30 mg/mL) and Tagrisso (osimertinib) 80 mg. with the aforementioned characteristics.
“If you have information about their marketing, you are encouraged to make the corresponding health report on the following page: health report. If you have consumed any of the mentioned products and present any adverse reaction or discomfort, you are requested to report it immediately through from the following link and to the email: pharmacovigilancia@cofepris.gob.mx”, the statement says.
Cofepris also urged distributors and marketers to validate the corresponding documents with the holder of the health registration before purchasing products.
He added that, when making transfers between public institutions, it is necessary to ensure the traceability of the legal acquisition of the products and the associated documentation, in addition to guaranteeing optimal storage conditions.
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And asked the pharmacies acquire medicines exclusively through authorized distributors validated by the company that owns the health registry, who must have a health license, operating notice and all documentation that guarantees the legality of the products.
With information from SUN.
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