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