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GELSYN-3

IBSA FARMACEUTICI ITALIA SRL · Model GS3111 · UDI-DI 08033638951057

MOZ
0
510(k) clearances
8,423
Adverse events (310 deaths)
2
Recalls
25
Facilities

Description

INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT

Recalls

DateFirmReason
2017-12-11Sanofi GenzymeContamination with Methylbacterium thiocyanatum
2010-04-16Ferring Pharmaceuticals IncOut of Specification results for molecular weight or viscosity through the established expiration date.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.