Class 4 Medicines Defect Information: Memantine 10mg Film-Coated Tablets, PL 20416/0260, (EL (20)A/11)
Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.
MDR Number
MDR 117-02/20
Company Name
Crescent Pharma Ltd
Product description
Memantine 10mg Film-Coated Tablets PL 20416/0260
| Batch Number | Expiry Date | Pack Size |
|---|---|---|
| 10819 | 08/2022 | 28 |
| 20819 | 08/2022 | 28 |
| 11119 | 11/2022 | 28 |
Brief description of the problem
Crescent Pharma Ltd has informed us of a discrepancy on the product packaging for the above batches. The discrepancy relates to the incorrect quantity printed on one side (end flap) of the packs in error. The incorrect end flap states that the quantity of tablets within the pack is 30, however this is incorrect and should state 28 as per all other sides of the pack, (see Annex 1 in ). The other product details on the pack including the name, strength and pharmaceutical form of the medicine are correct. .
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: Crescent Pharma Ltd. Medical Information Department on +00351 214643225, via email on tiago.barca@pharsolution.com or +44 (0) 1256 772740.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Download document: [