ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
This recall has been terminated (originally issued November 13, 2003).
- Company
- Anika Therapeutics
- Recall Initiated
- October 8, 2003
- Posted
- November 13, 2003
- Terminated
- August 9, 2004
- Recall Number
- Z-0108-04
- Quantity
- 10,100 units
- Firm Location
- Woburn, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Stability failure at the 20 month for viscosity specification
Distribution
CA, MO, NC,VA
Lot / Code Info
Lot Number: B020122B
Root Cause
Other
Action Taken
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
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