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The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect information notice for Co-careldopa 25mg/100mg tablets of Fairmed Healthcare with PL 20242/0028.

Fairmed Healthcare has 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

 

There is 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’. 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,” the Pharmaceutical Services Negotiating Committe (PSNC) has said in an alert notice.

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.

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