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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-1383-05 · Posted 2005-08-23

Recalling FirmAnika Therapeutics, Inc.
Recall StatusTerminated
Product CodeLZP
Date Initiated2005-07-14
Date Terminated2006-05-02
Product Quantity3720 units

Reason for Recall

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

Firm Action

Anika Therapeutics notified Distributor accounts by telephone on July 14. The letters were faxed and sent by Fedex on July 14. Distributors were provided with a end-user letter template letter for notification to their accounts.

Root Cause

Other

Distribution Pattern

CA, NC

Official Source

View FDA Recall →

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

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