Stallergènes Greer SAS recalls all allergen immunotherapy products, shipped from its Antony site as of August 13, 2015 and has temporarily suspended since December 2, at the request of the National Agency for the Safety of Medicines and Health Products (ANSM), production and the distribution of products manufactured on this site, following “difficulties” encountered in the deployment of its new computer system. For pharmaceutical specialties, the need for a product recall is being assessed.
This decision takes effect following the declarations on Wednesday 2 December 2015 from the ANSM which took a health police decision (DPS) against the company Stallergènes Greer SAS. The agency has imposed to suspend its activity until it is brought back into compliance.
“Stallergènes desensitization products are part of a basic treatment, for an expected effect in the more or less long term. Also, the temporary stopping of this type of desensitization treatment does not pose any particular difficulty for the health of the patients. In addition, the initiation of such treatment can be postponed because there is never an emergency ”recalls the ASNM in a press release.
If in doubt
“A letter will be sent in the coming days to all patients who have received APSI since August 13, 2015, asking them to stop the current treatment, to return their medication to Stallergenes (in a postage-paid envelope) and to make contact with their doctor who initiated their allergen immunotherapy treatment in order to adapt their treatment modalities ” informs the laboratory in a press release.
To manage these withdrawals, Stallergenes has set up two toll-free numbers:
One for doctors: 0 800 940 377
The other for patients: 0 800 940 390
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