Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for Bausch & Lomb Surgic
FDA device recall Z-0113-04 · posted 2003-11-13 · Terminated
Recall details
- Recalling firm
- Anika Therapeutics
- Reason for recall
- Stability failure at the 20 month for viscosity specification
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZP
- Quantity affected
- 6036 units
- Distribution
- CA, MO, NC,VA
- Date initiated
- 2003-10-08
- Date posted
- 2003-11-13
- Date terminated
- 2004-08-09
- Location
- Woburn, MA
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