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Anti-rabies vaccine from China recalled by USFDA on account of cGMP issues

All batches of an-anti rabies vaccine imported from Jilin province in China have been recalled by USFDA after the National Medical Products Administration of China found that the anti-rabies vaccine manufacturer, Changchun Changseng Life Sciences Ltd violated relevant requirements of GMP. Mainly data integrity issues were observed. The vaccine batches being recalled are (Verocell, Purified) 2.5 IU/0.5ml Lyophilized Powder for Injection (IM/SC) (Rabies Vax). The recall of all batches or lots exported to the Philippines is being processed due to GMP issues as rabies vaccines are widely used in this country.

The FDA has asked the distributors, hospitals, retailers, pharmacies or clinics that have batches/lots of the drug product to report any suspected adverse reaction experienced from the use of the said vaccine and have instructed to discontinue further distribution, sale and use. All consumers have also been advised not to purchase or use any further product/batch/lot.