Reported Feb 21, 2018 · Terminated
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight…
Sanofi Genzyme
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi Genzyme · 500 Kendall St · Cambridge, MA · 02142-1108
Is this the product you have?
Synvisc-One ¿ (hylan G-F 20)6mL delivered
- from a 10mL syringe Product UsageA elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen
- Lot codes and dates
- Lot Number7RSL021
- Expiration Date2020-05-31
- Amount recalled
- 12,380 units
Where it was sold
- Nationwide
Why it was recalled
Contamination with Methylbacterium thiocyanatum
This product could cause temporary or reversible health problems — stop using it.
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