FDA recalls rabies vaccine from China
The Food and Drug Administration (FDA) has ordered the recall of an antirabies vaccine imported from Jilin, China.
FDA Advisory No. 2018-270 identified the product as Rabies Vaccine (Verocell, Purified) 2.5 IU/0.5 mL Lyophilized Powder for Injection (IM/SC) (Rabiesvax-FD).
Earlier, the vaccine manufacturer, Changchun Changsheng Life Sciences Ltd., was found by Chinese officials to be in violation of good manufacturing practice requirements, particularly over problems in data integrity.
“Appropriate recall of the batches or lots of the said product is ongoing in China,” the FDA said.
It called on distributors, hospitals, retailers, pharmacies or clinics that have stocks of the vaccine to stop distributing, selling or using it.
Any suspected bad reaction from using the product should also be reported at once, it added.
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