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DATE RECALL INITIATED: April 16, 1999
PRODUCT / LOT NUMBER / EXPIRATION DATE:
FX80713 07/13/1999
FZ80612 06/12/1999
GY80616 06/16/1999
GZ80623 06/23/1999
FZ80701 07/01/1999
GW80630 06/30/1999
FZ80623 06/23/1999
MANUFACTURER:
V.I. Technologies, Inc.
Melville, NY
DISTRIBUTOR:
American Red Cross
Arlington, VA
REASON:
V.I. Technologies is voluntarily recalling seven lots of PLAS+ SD because in its conduct of Phase IV safety studies in normal volunteers, it was noted that several seroconversions to parvovirus B19, including documented viremia in some cases, occurred with two lots found to have a high titer of parvovirus B19 DNA as measured by PCR. There was no evidence of clinical disease typical of parvovirus B19 associated with these seroconversions. As noted in the product insert, parvovirus B19 most seriously affects pregnant women or immunocompromised individuals. Therefore, physicians and healthcare practitioners should exercise caution when using this product in these patients.
Voluntary recall of these lots is intended to reduce risk from parvovirus B19 infection. Only one lot of the two lots associated with the Phase IV safety study is in general circulation. Based on a provisional cut off, VITEX PCR testing detected an additional six lots of PLAS+ SD with high levels of parvovirus B19 DNA.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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