MHRA Class 3 Medicines Recall: Glucophage® SR 500 mg, 750mg and 1000mg prolonged-release tablets (Bruno Farmaceutici SpA, Italy)
MHRA Class 3 Medicines Recall: Glucophage® SR 500 mg, 750mg and 1000mg prolonged-release tablets (Bruno Farmaceutici SpA, Italy) PL: Parallel Imports from the Italian market
Date issued: 20 February 2025
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall notice for: Glucophage® SR 500mg, 750mg and 1000mg Prolonged-release Tablets
PL: Parallel Imports from the Italian market
DMRC reference number: DMRC-34710077
Company name: Bruno Farmaceutici SpA, Italy
Glucophage® SR 500mg Prolonged-release Tablets
Distributed by:
- Uni Health Distribution (Savio Industrial S.r.L.or Special Product’s Line SpA) PLPI: 45396/0282
For affected Lot batch numbers – See Annex A of attachment
Glucophage® SR 750mg Prolonged-release Tablets
Distributed by:
- Uni Health Distribution (Savio Industrial S.r.L.or Special Product’s Line SpA) PLPI: 45396/0209
- Star Pharmaceuticals Ltd PLPI 20636/2830
- B&S Healthcare PLPI 18799/3083
For affected Lot batch numbers – See Annex B of attachment
Glucophage® SR 1000mg Prolonged-release Tablets
Distributed by:
- PilsCo Ltd. PLPI 39467/0487
- Uni Health Distribution (Savio Industrial S.r.L.or Special Product’s Line SpA) PLPI 45396/0253
- Star Pharmaceuticals Ltd PLPI: 20636/2831
- B&S Healthcare Limited PLPI 18799/3084
- Quadrant Pharmaceuticals Limited PLPI 20774/1773
- G Pharma Ltd PLPI 16369/1818
For affected Lot batch numbers – See Annex C of attachment
Brief description of the problem
The batches specified in Annexes A-C of the above products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the incorrect grade of an excipient. The hydroxypropyl methylcellulose used in the manufacture had a viscosity level out of the authorised specification.
Advice for healthcare professionals
Stop supplying the annexed batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for type 2 diabetes is higher than the potential risk presented by the incorrect excipient used. The recall impacts parallel imports from Italy only.
View full alert here.
Advice for patients
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. There have been no reports of patients being harmed or becoming ill from taking this medicine. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Never stop taking medications used for treating diabetes without first seeking medical advice.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Further Information
- For PilsCo Ltd. stock control enquiries please contact pmccourt@ethigen.co.uk
- For Uni Health Distribution (Savio Industrial S.r.L.or Special Product’s Line SpA) stock control enquiries please contact info@uhdltd.co.uk
- For Star Pharmaceuticals Limited stock control and recall enquiries please contact recall@drugsrus.co.uk
- For B&S Quality group and Customer Service enquiries please contact qa@bnshealthcare.com & customerservices@bnsdistribution.uk
- For Quadrant Pharmaceuticals stock control and recall enquiries please contact Angeline.Rees@Maxearn.co.uk
For further medical information enquiries please contact: info@bruno.org
