FDA Device

Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.

Hazard

Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.

What You Should Do

Remedy

Celsus notified their customers by e-mail on April 24, 2008, explaining that oversulfated chondroitin was found in a batch of crude heparin they received from their supplier. Celsus recommended the device manufacturers quarantine material from the specified lots.

Products

Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.
Brand
Celsus Laboratories Inc
UPC
Lot# HL-31707, HL-31807, HL-32708, HL-32808 & HL-32908

Units Affected

HL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g, HL-32808=12,128g & HL-32908=5,000g