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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Hymenoptera (Honey Bee) Venom Products - Hollister-Stier Laboratories

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.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002