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The National Consumer Service (Sernac) reiterated a security alert after Laboratorios Andrómaco SA informed it that batches of two of its contraceptives had a “Decrease in the potency of active ingredients”.
This situation had already been warned by the Institute of Public Health (ISP) in October.
These are lots of brand name birth control pills Minigest-15 and Minigest-20, marketed during November 2019 and September 2020.
-Products in consumers: 4,787.
Affected lots:
1. D19129A – D19130A (Minigest-15 paragraph).
2. D19132A (Minigest-20 paragraph).
A stability study detected “a decrease in the potency of active ingredients ”.
Sernac reported in its alert that the risk for women who consumed the pill is “possible disorder of the hormonal cycle or possible decrease in efficacy.”
“It should be noted that the series related to voluntary and preventive withdrawal from the market were released for distribution complying with the specification and parameters required in the sanitary registry and that this decrease in the potency of active principles occurred during the course of the stability study for both products ”, clarified Sernac in the alert text.
The start of the market recall “was at the level of distributors on 10-05-2020 in accordance with the regulations set forth by the Public Health Institute (ISP)”.
Similar case
On the 11th of this month, the Chilean College of Chemists-Pharmacists and Biochemists called on the Grünenthal group and the authority to take responsibility for the complaints of unwanted pregnant women that would have been caused by the use of the contraceptive AnuletteCD, to which a failure in the packaging was registered.
The president of the professional order, Ana Victoria Nieto, accused that “the main person in charge of the defective products, is the holder of the sanitary registry Laboratorios Silesia SA and the manufacturer laboratory Laboratorios Andrómaco SA, both of the Grünenthal Group”.
The complaint was made by the Miles Corporation, who indicated that at least 29 women became pregnant after using this contraceptive, which was distributed both in pharmacies and in doctors’ offices, for which they ask to be able to access an abortion and compensation.
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