Vaccines, Blood & Biologics

Recall of Standardized Bermuda Grass Pollen Allergenic Extract

DATE NOTIFICATION INITIATED:

January 13, 2014

PRODUCT / LOT NUMBER

Standardized Bermuda Grass Pollen Allergenic Extract, 10,000 BAU/ML

Lot # B29032613

MANUFACTURER:

Antigen Laboratories

Liberty, Missouri

REASON:

Greer Laboratories is initiating a Voluntary Recall for Standardized Bermuda Grass Pollen Allergenic Extract, 10,000 BAU/mL (Lot # B29032613) manufactured by Antigen Laboratories, Inc. The product is being recalled because ongoing stability evaluations indicate a decrease in potency for this lot. It is expected that the risk to patients is minimal. No adverse reactions or complaints have been reported in association with the use of this extract lot. Consignees are asked to discontinue use of this product. All vials labeled as Standardized Bermuda Grass Pollen Allergenic Extract, 10,000 BAU/mL (Lot # B29032613) should be returned to GREER, whether opened or unopened.


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.