Withdrawal of Varicella-Zoster Immune Globulin (Human) and Immune Globulin (Human)

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Withdrawal of Varicella-Zoster Immune Globulin (Human) and Immune Globulin (Human)

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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