Events

Recall of Eosine 2%, 50ml and 100ml dry solution

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by FRENCH PHARMACEUTICAL COOPERATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2010-06-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/eosine-2-solution-assechante-50ml-et-100ml-cooperation-pharmaceutique-francais-rappel-de-lot
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    The COOPER Laboratories, in agreement with Afssaps and as a precautionary measure, recall the batches: 3971, 4248, 4283, 4528, 4529, 4530, 4531 of the product "EOSINE 2% COOPER solution drying" presented in bottles of 50 and 100 ml. Indeed, the presence of a microbiological contamination by a non-pathogenic germ was identified on these lots although the control before release on sale did not reveal any anomaly. Given the population concerned, it is recommended not to use these vials and bring them back to the pharmacy. An information point. for the patient will also be available on the Afssaps website.

Device

Eosine 2%, 50ml and 100ml dry solution

Manufacturer

FRENCH PHARMACEUTICAL COOPERATION
  • Source
    LAANSM