Anika Therapeutics ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
Brand
Anika Therapeutics
Lot Codes / Batch Numbers
Lot Number: B020122B
Products Sold
Lot Number: B020122B
Anika Therapeutics is recalling ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product N due to Stability failure at the 20 month for viscosity specification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability failure at the 20 month for viscosity specification
Recommended Action
Per FDA guidance
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MO, NC, VA
Page updated: Jan 10, 2026