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Terminated

ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC

FDA Recall Z-0108-04 · Posted 2003-11-13

Recalling FirmAnika Therapeutics
Recall StatusTerminated
Product CodeLZP
Date Initiated2003-10-08
Date Terminated2004-08-09
Product Quantity10,100 units

Reason for Recall

Stability failure at the 20 month for viscosity specification

Firm Action

Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.

Root Cause

Other

Distribution Pattern

CA, MO, NC,VA

Official Source

View FDA Recall →

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

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