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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448