HYDERABAD, MAY 18, 2024: It has come to the attention of the Drugs Control Administration, Telangana, that a counterfeit version of Pulmosil Injection (Sildenafil Injection) 10 mg/12.5 ml, Batch No. KFA0300, Mfg. Dt. 06/23, Exp. Dt. 05/25 purported to be manufactured by Sun Pharmaceutical Industries Ltd. at Sy. No. 250-252, Turkapally (V), Shamirpet (Mandal), Medchal-Malkajgiri District, Telangana is circulating in the market.
DCA Director-General VB Kamalasan Reddy said that the officials have found fungus n the sealed vials of the counterfeit version of the product Pulmosil Injection. In light of these grave findings, the Drugs Control Administration, Telangana, hereby issues a Spurious/Counterfeit Drug Alert and Stop Use Notice regarding the counterfeit version of Pulmosil Injection.
This counterfeit product may be identified by the following observations. Counterfeit Vs Original – Pulmosil Injection 10 mg/12.5 ml Batch No. KFA0300 Physical Parameters Counterfeit – Pulmosil Injection 10 mg/12.5 ml Batch No. KFA0300 Original – Pulmosil Injection 10 mg/12.5 ml Batch No. KFA0300 Vial: Flip-Off Seal Colour White Flip-Off Seal Violet Flip-Off Seal Label: Edges Vial label – sharp edged labels (straight edges) Vial label – curve edged labels (rounded corners) Contents Light pale yellow colour solution – Fungus like Clear colourless solution contamination observed inside the vial. 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 – to discontinue the use of the counterfeit version of Pulmosil.
Retailers and wholesalers are directed to STOP the sale and distribution of the counterfeit version of Pulmosil Injection. DCA is actively working to ensure the removal of the spurious drugs from the market. Drugs Control Administration urges the public to remain vigilant and report any information regarding the distribution or sale of the counterfeit version of Pulmosil Injection to the nearest Drugs Control Administration Office – You may report to the local Drugs Inspector or Assistant Director, Drug Control Administration.
The details of the contact number and address of the office are available on the Drugs Control Administration, Telangana website https://dca.telangana.gov.in/ under the ‘Key Contacts’ section (or) to the Drugs Control Administration, Telangana Toll-Free Number 1800- 599-6969, which is operational from 10:30 am to 5:00 pm on all working days.
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