Mr. Curtis Lockshin reports
SCIVAC THERAPEUTICS ANNOUNCES PRECAUTIONARY RECALL OF SCI-B-VAC
Following discussions with the Israeli Ministry of Health (IMOH),
SciVac Therapeutics Inc. is recalling from the market all Sci-B-Vac sold by the company from Jan. 1, 2012, to the present.
The company is carrying out the recall solely as a precautionary measure, as, following inspection by SciVac, it was determined that certain unshipped packages of the Sci-B-Vac hepatitis B vaccine contained a small number of damaged vials. SciVac then reported its findings to the IMOH. There have been no reports of harm to any patients, nor have there been any reports with respect to Sci-B-Vac's efficacy or safety. Currently, the company believes that an issue in the labelling process caused the damage, and the IMOH informed the company that it may continue manufacturing Sci-B-Vac uninterrupted, so long as the company uses an alternative labelling process until the issue can be appropriately remedied. The company is diligently investigating the failure that resulted in the damaged vials.
The recall primarily affects the Israeli and Hong Kong markets.
We seek Safe Harbor.
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