The Telangana DCA issued a fake drug alert and stop-use notice over the counterfeit Sildenafil injection after finding fungus in it.
The Drug Control Administration (DCA) of Telangana has issued an alert regarding counterfeit drugs used to treat pulmonary arterial hypertension and erectile dysfunction.
In a statement, the DCA reported that a counterfeit version of the Pulmosil injection (Sildenafil injection) was circulating in the market.
The dosage of the counterfeit injection was 10 mg or 12.5 ml, the batch number KFA0300, the manufacturing date was June 2023, and the expiry date was May 2025.
The DCA also noted that Sun Pharmaceutical Industries Ltd — registered at Turkapally in the Shamirpet Mandal of the Medchal-Malkajgiri district in Telangana — purportedly manufactured the injection
“Fungus has been observed in the sealed vials of the counterfeit version of Pulmosil Injection 10 mg/12.5 ml, Batch No. KFA0300, Mfg. Date 06/23, Exp. Date 05/25,” said Telangana DCA Director General VB Kamalasan Reddy in a statement.
Pulmosil injection is a medication primarily used to treat pulmonary arterial hypertension (PAH) in adults. This medication works by reducing blood pressure within the lungs.
Sildenafil — the active ingredient — blocks certain enzymes (PDE5) that limit blood flow to the lungs.
As a result, it widens the blood vessels supplying the lungs, improves blood supply, and enhances pulmonary function.
It is important to note that the Pulmosil 10 mg/12.5 ml injection should only be administered intravenously by a healthcare professional.
The correct dosage and duration of therapy should be determined by a doctor based on factors such as the patient’s age, body weight, and specific condition.
Additionally, the injection is generally not recommended for use in pregnant women unless deemed necessary by a physician.
Women of childbearing potential should use proper contraceptive methods to avoid pregnancy while undergoing therapy with this medication. It should also be used with caution in breastfeeding women.
The Pulmosil injection is also used to treat other conditions, such as sex-related issues, based on its formulation.
The Pulmosil 0.8mg injection is primarily used to treat erectile dysfunction in adult men by relaxing the blood vessels in the penis to allow blood flow during sexual arousal, functioning similarly to Viagra.
This medication works by relaxing the blood vessels in the penis, which allows blood to flow into the penis and produce an erection when sexually aroused.
Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation, but it only helps achieve an erection if the person is sexually stimulated.
In light of its findings, the Telangana DCA issued a spurious/counterfeit drug alert and stop-use notice regarding the counterfeit version of the Pulmosil injection.
According to the DCA, the counterfeit injection can be identified by a white flip-off seal and sharp-edged vial labels (straight edges).
The contents inside are a light pale yellow solution with fungus-like contamination observed inside the vial.
In contrast, the original Pulmosil 10 mg/12.5 ml Injection — with Batch No KFA0300 — has a violet flip-off seal, curved-edged vial labels (rounded corners), and a clear, colourless solution.
“The counterfeit drugs are manufactured by anti-social elements and pose significant health risks to consumers. Consumers and healthcare professionals are informed to STOP USE immediately and discontinue the use of the counterfeit version of Pulmosil Injection,” said the DCA director-general in a statement.
“Retailers and wholesalers are directed to stop the sale and distribution of the counterfeit version of Pulmosil injection and to inform the area drugs inspector immediately,” he added.
(Edited by Arkadev Ghoshal)
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