WITHDRAWAL DATE: April 22, 1998
PRODUCTS / LOT NUMBERS / EXPIRATION DATES:
Varicella-Zoster Immune Globulin (Human), 100
AU/ml (1.25 ml):
MVZIG-58, 6/03/99
Immune Globulin (Human), (2ml):
ISG-111, 5/06/99
MANUFACTURER:
Massachusetts Public Health Biologic Laboratories
Boston, MA
REASON:
Massachusetts Public Health Biologic Laboratories is withdrawing
the above lots of product due to post-release stability testing in
which both lots showed an increase in pH during the third year of
its dating period. The acceptance range for pH for both products is
6.4-7.2; the pH of both lots were 7.14.
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.
Last Updated: 1/31/2001
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