Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the packs in error.

MDR Number

MDR 017-07/20

Company name

Fairmed Healthcare GmbH

Product description

Batch number Expiry date Pack size Market Release
DT1912007A 30/11/2022 100 03/04/2020
DT1912006A 30/11/2022 100 03/04/2020
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

Active pharmaceutical ingredients: carbidopa/levodopa

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 in the attached document below). 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

Additional information

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this notice.

NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Download document

Class 4 Medicines Defect Information, Co-Careldopa 25mg/100mg tablets, (PL 20242/0028), EL (20)A/59