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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Limulus Amebocyte Lysate (LAL), Pyrotell-Associates of Cape Cod, Inc

DATE RECALL INITIATED:

 

July 14, 2004

LOT NUMBER / EXPIRATION DATE :

 

201-07-211      7/19/2006

 

MANUFACTURER:

Associates of Cape Cod, Inc.
Falmouth, MA

 

REASON:

 

Internal testing by Associates of Cape Cod, Inc. discovered that one lot of Pyrotell (2mL/vial, Lot # 201-07-211) showed moisture content slightly above specification. Upon discovery, the performance of this lot was re-confirmed in that the label claim (sensitivity) continues to meet specification. Consignees have been asked to contact the manufacturer to arrange for product return.

 

 

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