Glaxosmithkline (GSK) Consumer Healthcare, holder of the sanitary registration of Today Condoms with lubricant and spermicide – Today natural rubber latex condom in Colombia, announced that it has already withdrawn lot 2106572316, which according to Invima presented a non-compliant result according to a hole detection test.
The company in a statement, He stated that since January 2022, when they were notified by the health authority of the inconsistencies in the product, the withdrawal of the units in the country began.
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“In October 2021, Invima, as part of its “Demonstrates quality” program, carried out a random sampling of several batches and references from the Today Condoms portfolio and found that, of 811 units of batch 2106572316 of the product Today Condoms Lubricated with Spermicide analyzed, 3 units presented a non-compliant result in their hole detection test, complying in accordance with the rest of the tests carried out,” the statement said.
He stressed that the company was notified by Invima of the result of these evaluations in January 2022.
“The company immediately stopped the marketing of lot 2106572316 of the product in question and began the process of withdrawing the units from the market,” he said.
He added that in At present, the product in a large part of the national territory was withdrawn.
“To date, GSK Consumer Healthcare confirms that the preventive product recall process was carried out quickly and rigorously in accordance with the strict protocols established by the company, ensuring that 91.5% of the batch never reached the final consumer,” highlighted.
He pointed out that if consumers have any doubts or present an unfavorable situation with the use of the product, You can contact the Customer Service team.
“You can communicate through the email [email protected] or to the Customer Service telephone line: 18000127333, channels through which each of the reported cases will be followed up, in line with the product’s post-marketing surveillance protocols,” the document underlined.
RCN Mundo learned the details of the evaluation carried out by the health authorities of this lot, which had 261,072 units.
On October 19, 2021, Invima within the framework of its program “Shows the quality” performed a random sampling of several batches and references from the Today Condoms portfolio, taking a sample of 811 units from batch 2106572316 of the product Today Condoms Lubricated and with Spermicide.
On January 25, 2022, Invima notified via mail the non-conformity results of the tests carried out in October, where 3 units of the 811 taken for sample, presented a non-conforming result in their hole detection test, complying with compliance with the rest of the tests performed.
On January 27, 2022, Invima arrived at the company’s warehouses GSK Consumer Healthcare for the application of sanitary measure, Therefore, 163,455 units located in the GSK warehouse of Lot 2106572316 of Today Lubricated Condoms and with Spermicide were seized.
In that same visit, Invima asked GSK to start the process of withdrawing the units that were on the market.
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After the alert on January 31, 2022, the GSK company notified its customers about the start of the withdrawal of the 96,816 units that were marketed.
According to the report on February 4, 2022 GSK notified Invima of the start of the product withdrawal process from the market.
On March 17, 2022, according to the company GSK, the product withdrawal process was completed, recovering 74,715 units (77% of the units sold).
The company stated that after the recovery of the condom units, it is concluded that 91.5% of the manufactured units of lot 2106572316 of the product Today Condoms Lubricated with Spermicide never reached the final consumer.
The company revealed that 238,981 units of condoms from that batch were never marketed, which is equivalent to 91.5% of the quantity of the total imported batch, which was 261,072 units.
