Neo Citran - Pulver für Erwachsene

Recall | Medicines | 04/08/2020

The marketing authorisation holder informed its customers by August 01, 2020 that the package leaflet of seven batches of "Neo Citran - Pulver für Erwachsene" contains incorrect information for pregnancy and breast-feeding.

Based on a PRAC (Pharmacovigilance Risk Assessment Committee) recommendation for paracetamol (also paracetamol-containing combination products), its use in pregnancy was permitted (March 2019). Therefore the wording in the package leafleat for pregnancy and breast-feeding changed. However, "Neo Citran - Pulver für Erwachsene" also contains phenylephrine hydrochloride, which is contraindicated during pregnancy. Therefore, this amendment of March 2019 has been revoked and the affected batches having the incorrectly revised leaflet as of May 2019 are recalled.

Name of the medicinal product Neo Citran - Pulver für Erwachsene
Marketing authorisation number(s) 1-19371
CIP code 1257681
Marketing authorisation holder Novartis Pharma GmbH
Batch number(s) Batch, Expiry date
M3930, 11.2021
M3792, 10.2021
M3856, 11.2021
M3858, 11.2021
M3928, 11.2021
M3929, 11.2021
M3931, 11.2021
Classification of the recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-3270

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