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Terminated

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

FDA Recall Z-1917-2008 · Posted 2008-07-18

Recalling FirmCelsus Laboratories Inc
Recall StatusTerminated
Product CodeJKA
Date Initiated2008-03-31
Date Terminated2012-09-21
Product QuantityHL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g, HL-32808=12,128g & HL-32908=5,000g

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution. The Lithium Heparin was sold to companies in USA (Nebraska, New Jersey, Ohio), Puerto Rico, Austria, and Denmark.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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