Synvisc® / Synvisc-One®

⚠️ Rappels (recalls) FDA

• D-1744-2015

  Class II

  Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

  20150602 · Terminated

• D-518-2014

  Class II

  Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500

  20130702 · Terminated

• D-0165-2018

  Class II

  Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

  20171116 · Terminated

• D-0081-2026

  Class II

  Lack of Assurance of Sterility

  20250730 · Ongoing

• D-0375-2019

  Class II

  CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

  20190102 · Terminated

Avis HAS — Commission de la Transparence

• S in SYNVISC ntra-articu C-ONE (H ulaire HYLANE G-F 20), solution E D’EVALU d’acide hyaluron ique pou r injectio n

  Mon, 15 Dec 2014 08:00:00 GMT

• S SINOVIAL L, solutio n d’acide e hyaluron nique pou E D’EVALU ur injectio on intra-a articulaire e

  Sat, 13 Jul 2019 08:16:54 GMT

• O OSTENIL L, solution n d’acide hyaluron nique pou E D’EVALU ur injectio n intra-ar rticulaire

  Sat, 27 Jul 2019 11:03:06 GMT

Source HAS via Google News RSS · avis SMR/ASMR officiels.

Avis HAS CNEDiMTS — Dispositifs / Numérique

• SYNVISC Hylane G-F 20 1958

Ressources patient & prescripteur

• Notice ANSM SYNVISC

  notice

• Avis HAS — Commission de la Transparence

  has

• Fiche patient Vidal Eureka Santé

  notice