Recall

Hymenoptera Venom Products

DATE RECALL INITIATED:

January 29, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Honey Bee Venom
Apis mellifera Venomil

Maintenance Dose Set
Item Code: 6781U2
Set Lot Number: M11316D
Expiration Date: 1/1/2010
Set contains 6 Honey Bee Vials

Diagnostic Set
Item Code: 6781U0
Set Lot Number: D11316C
Expiration Date: 1/1/2010
Set contains 1 Honey Bee Vial

MANUFACTURER:

Hollister-Stier Laboratories, LLC
Spokane, Washington

REASON:

This product is being voluntarily recalled because the Honey Bee Venom vials in these packages state an incorrect strength on the vial label. The vial label indicates 100mg/mL; it should state 100ug/mL. The contents of the vial are correct. Upon reconstitution with 1.2mL of diluent the vial would contain 100ug/mL. The Package Label and the Package Insert both correctly state ug/mL. If physicians follow the reconstitution directions on the Package Label and Package Insert the resulting product would be 100ug/mL. Customers are asked to return all product to Hollister-Stier.

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.