✓ verbatim from the press ? no verbatim passage
The National Health Surveillance Agency (Anvisa) ordered on June 18, 2026, the recall and suspension of sales of three batches of injectable medications due to quality deviations that may pose risks to patients. The measure, published in the Federal Official Gazette, affects batch 2519879 of the antibiotic Polycid (União Química Farmacêutica Nacional), batch 24101854 of clindamycin phosphate 150 mg/ml (Hypofarma), and batch 2513588 of Equiplex Sodium Chloride Physiological Solution 9 mg/ml. ?
Press quotes (2)
"A Agência Nacional de Vigilância Sanitária (Anvisa) determinou o recolhimento e a suspensão da comercialização, distribuição e uso de três lotes de medicamentos após a identificação de problemas de qualidade que podem representar risco aos pacientes. A medida foi publicada nesta quinta-feira (18) no Diário Oficial da União e atinge um lote do antibiótico Polycid, da União Química, um lote de fosfato de clindamicina, da Hypofarma, e um lote de soro fisiológico da Equiplex."
"A resolução atinge o lote 2519879 do antibiótico Polycid, fabricado pela União Química Farmacêutica Nacional... A resolução atinge ainda o lote 24101854 do antibiótico fosfato de clindamicina 150 mg/ml solução injetável (caixa com 50 ampolas), fabricado pela Hypofarma... Outro produto alvo da resolução é a solução fisiológica de cloreto de sódio Equiplex – 9mg/ml... o lote 2513588"
According to Anvisa, União Química initiated a voluntary recall of the Polycid batch after identifying a glass fragment inside an intact vial of the medication. The product is used to treat serious infections. ✓
Press quotes (1)
"A Anvisa recebeu comunicado de recolhimento voluntário iniciado pelo próprio fabricante por conta da presença de um pedaço de vidro no interior do frasco do medicamento."
The Hypofarma clindamycin phosphate batch showed quality deviation with yellowish solution, presence of foreign bodies and precipitates inside sealed vials. In a statement, Hypofarma reported that the resolution is being handled in accordance with applicable regulatory protocols and in alignment with the health authority, maintaining full cooperation with competent bodies. ✓
Press quotes (2)
"foi confirmado desvio referente à solução de cor amarelada, incluindo a presença de corpos estranhos e precipitados no interior do frasco lacrado do medicamento."
"A companhia mantém colaboração integral com os órgãos competentes e segue adotando todas as medidas adequadas e cabíveis no âmbito de seus processos internos e regulatórios."
Batch 2513588 of Equiplex Sodium Chloride Physiological Solution, valid until June 30, 2027, was recalled for not complying with manufacturing standards. Anvisa determined that the product cannot be sold, distributed or used. ✓
Press quotes (2)
"o lote 2513588 (validade 30/6/2027) apresentou desvio de qualidade e deve ser recolhido."
"O produto também não pode ser vendido, distribuído ou utilizado"
Three batches of injectable medications were subject to recall due to quality problems: Polycid (União Química, batch 2519879), clindamycin phosphate (Hypofarma, batch 24101854) and Equiplex Physiological Solution (batch 2513588).
The Polycid recall was initiated voluntarily by União Química after identifying a glass fragment in an intact vial.
The clindamycin phosphate batch showed yellowish solution, foreign bodies and precipitates in sealed vials.
Covered by only some sources, or where the accounts diverge.
Covered by only some sources (2)
Hypofarma issued a statement saying the resolution is being handled in accordance with regulatory protocols and in full collaboration with competent bodies.
Anvisa's resolution also ordered the recall of all compounded preparations produced by Farmácia S J do Jabour Ltda for irregular marketing of standardized compounded products without prescription.
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What is the specific legal basis invoked by Anvisa to order the mandatory recall?
Why it's still unknown: The articles cite only that the resolution was published in the Federal Official Gazette, without mentioning which article of Law No. 6,360/1976 or RDC resolution serves as the legal basis for the precautionary recall measure.
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How many units of each batch are in circulation and what is the actual market exposure?
Why it's still unknown: No source specified the size of the affected batches, how many units were distributed to pharmacies or hospitals, or the market share of the products — essential data to assess the magnitude of the health risk.
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Were there reports of adverse events to patients or is the measure exclusively preventive?
Why it's still unknown: The articles mention 'risk to patients' without clarifying whether there were concrete cases of harm (adverse reactions, injuries from glass fragment) or if the recall was triggered only by laboratory identification of non-conformities.
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What is the risk classification (Class I, II or III) assigned by Anvisa to each recall?
Why it's still unknown: Anvisa classifies recalls by severity (Class I: serious risk of death or injury; Class II: reversible risk; Class III: low probability of harm), but no source specified the category applied to the three batches.
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Did Anvisa coordinate stock replacement to avoid shortages of injectable antibiotics in hospitals?
Why it's still unknown: Polycid and clindamycin phosphate are hospital-use antibiotics for serious infections. No article clarified whether the agency engaged alternative manufacturers or if there is a risk of shortage during the recall period.