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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
(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