Anvisa orders the collection of infant formula manufactured by a compounding pharmacy in SC without sanitary regularization
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Powder compound Joana Caldas/g1 The National Health Surveillance Agency (Anvisa) ordered the recall of 1st and 2nd Infancy infant formula from the Essentia Pharma brand, made by the compounding pharmacy HKM, in Palhoça, in Greater Florianópolis.
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Joana Caldas/g1
The National Health Surveillance Agency (Anvisa) ordered the recall of 1st and 2nd Infancy infant formula from the Essentia Pharma brand, made by the compounding pharmacy HKM, in Palhoça, in Greater Florianópolis. According to the national body, the product is being marketed as not having adequate health regulation.
g1 contacted the pharmacy and had not received a response until the last update of this report.
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The measure was published on Monday (8) by Anvisa. It also suspends marketing, distribution, manufacturing, advertising and use.
According to Anvisa, there is no proof of compliance with the composition, safety, stability, microbiological quality and nutritional adequacy requirements required for infant formulas.
In addition to not having adequate health regulation, the product uses labels, information and claims that may lead the consumer to believe that it is an authorized infant formula.
Anvisa highlighted that this exposes young children to health risks and can mislead consumers regarding the nature and quality of the product.
The agency, however, did not say whether the product recall operation had already been carried out or how it should be carried out. g1 also contacted Palhoça City Hall to find out if Municipal Surveillance had been notified and had not received a response until the last update of this report.
Pharmacy has already had more than a million injectable medicines banned
In March, this same compounding pharmacy had more than one million irregular injectable medications, of various types, banned. This occurred during an inspection by Anvisa and the state's Health Surveillance.
According to the agency, the site operated on an industrial scale without requiring a medical prescription, in addition to presenting "critical flaws in the product sterilization processes." 1,356,488 pre-produced units were found that were already waiting for future consumers even without a prescription — which is prohibited.
🔎 Production in any compounding pharmacy, according to Anvisa, "can only occur to meet a specific, prior and individualized prescription".
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