Class 4 Medicines Defect Information: Co-careldopa 25mg/100mg tablets (Fairmed Healthcare GmbH)

Class 4 Medicines Defect Information: Co-careldopa 25mg/100mg tablets (Fairmed Healthcare GmbH)

December 15, 2020

Class 4 Medicines Defect Information: Co-careldopa 25mg/100mg tablets (Fairmed Healthcare GmbH)

Drug alert number: EL (20)A/59

Date issued: 15 December 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Co-careldopa 25mg/100mg tablets (Fairmed Healthcare GmbH) PL 20242/0028

Fairmed Healthcare GmbH have informed the MHRA of a discrepancy on the product packaging for the batches below.

Batch Number Expiry Date Pack Size First Distributed
DT1912007A 30/11/2022 100 03 April 2020
DT1912006A 30/11/2022 100 03 April 2020
DT1910014B 30/09/2022 100 19/02/2020
DT1900015A 30/09/2022 100 19/02/2020
DRA07037A 30/06/2023 100 19/10/2020
DRA07036A 30/06/2023 100 04/09/2020
DRA01030A 31/12/2022 100 04/06/2020

Brief description of the problem
Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for the above batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side (end flap) of the packs in error. The incorrect end flap states that the active pharmaceutical ingredient is ‘carbiopa’ instead of ‘carbidopa’, (see Annex 1). The other product details on the pack including the name, strength and pharmaceutical form of the medicine are correct on all other sides of the carton

Advice for healthcare professionals
Healthcare professionals are advised to exercise caution when dispensing the product. There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time.

Further Information
For more information or medical information queries, please contact: Fairmed Healthcare GmbH Dorotheenstraße 48, 22301 Hamburg, Germany, Quality Assurance Department or via email on QA Manager: l.rozikova@fair-med.com

View the full alert here.

 



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