169 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 904kb
In force — no superseding record on file.
File No. X-11026/41/17-BD Directorate General of Health Services Ministry of Health and Family Welfare Central Drugs Standard Control Organization Office of Drugs Controller General (India) (Biological Division)
:
To
FDA Bhawan, Kotla Road, New Delhi- 110 002, India Dated: fe i 4 MAR 2018
- All States/UT Drugs Controllers 2. All CDSCO Zonal/Sub-Zonal offices
Subject: Peda Typh (Vi-Conjugate Typhoid Vaccine) (One dose), Batch No. TC010915 (CDL No. 453/2018) and Batch No. TC010417 (CDL No. 454/2018), manufactured by M/s Bio Med Pvt. Ltd, Ghaziabad - regarding.
Sir/Madam,
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It has been reported that the samples of Peda Typh (Vi-Conjugate Typhoid Vaccine) (One dose), Batch No. TC010915 (CDL No. 453/2018) and Batch No. TC010417 (CDL No. 454/2018), manufactured by M/s Biomed Pvt. Ltd. Ghaziabad have been declared as Not of Standard Quality (NSQ) by CDL, Kasauli with respect to Vi Polysaccharide content vide test report no. CDL/2018/752,753 and CDL/2018/754,755 dated 09.02.2018.
In this regard, all States/UT Drugs Controllers, CDSCO Zonal/Sub-Zonal officers are requested to direct the inspectorate staffs under their control to keep strict vigil on the movement of said product (Batch Nos. TC010915 & TC010417) in the market.
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(Dr. S. Eswara[Reddy)] Drugs Controller General (India)
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