Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for Bausch & Lomb Surgical,Irvine,CA and
FDA Recall Z-0113-04 · Posted 2003-11-13
Recalling FirmAnika Therapeutics
Recall StatusTerminated
Product CodeLZP
Date Initiated2003-10-08
Date Terminated2004-08-09
Product Quantity6036 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.