GovWire

MDR number

MDR 024-05/23

Company name

PHARMATHEN S.A.

Product name

Grepid 75 mg film coated tablets (Kent Pharma Livery), PLGB 17277/0398

SNOMED Code

15907411000001101

Active Pharmaceutical Ingredient: Clopidogrel

Brief description of the problem

PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine POM. This only impacts the batches listed in this notification.

A previous notification for this issue was issued in 2023, which included 10 batches of Grepid. The further batches in this notification were identified following a more detailed review by PHARMATHEN S.A. of all previous batches.

PHARMATHEN S.A. has confirmed that all future manufactured batches will include POM on the outer carton (box). There is no impact to the product quality or safety and due to considerations that clopidogrel is only available as a Prescription Only Medicine, these batches are not being recalled.

Advice for healthcare professionals

Healthcare professionals are advised to exercise caution when handling the listed products and ensure that they are stored accordingly and in line with the guidance for the storage of Prescription Only Medicines (POM). Additionally, healthcare professionals are reminded to only dispense these products when the pharmacy team receives a suitable prescription prescribed by a qualified health professional.

Advice for patients

This issue is about missing information on the outer carton (box). The medicine itself is not affected and therefore patients do not need to take any action.

This product will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRAYellow Card scheme.

Further Information

For more information, medical or supply enquiries, please contact telephone: +30 210 6604300 or via email: pharmacovigilance@pharmathen.com & info@pharmathen.com

Recipients of this Medicines Notification 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.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

Class 4 Medicines Defect Information: PHARMATHEN S.A., Grepid 75 mg film coated tablets (Kent Pharma Livery), EL(24)A/24