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Recall of Hymenoptera Venom Diagnostic,
White-Faced Hornet Venom Protein


DATE RECALL INITIATED:

August 22, 2002

LOT NUMBER / EXPIRATION DATE:

D87572A     2/1/2005

MANUFACTURER:

Hollister-Stier Laboratories LLC
Spokane, WA

REASON:

The recalling firm identified a mislabeling in the package insert for Hymenoptera Venom Diagnostic (White- Faced Hornet Venom Protein). The package insert, page one, lists mannitol as 7.7 mg/mL, while the correct value is 4.0 mg/mL. The outer box states the correct content. Customers will receive a copy of the corrected package insert.


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: 9/9/2002