Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07

All batches of the named 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.

From:
Medicines and Healthcare products Regulatory Agency
Published
20 February 2025
Message type:
Medicines recall/notification
Medical specialty:
Dispensing GP practices, General practice and Pharmacy
Issued:
20 February 2025

DMRC reference number

DMRC-34710077

Medicine Details

Glucophage SR 500mg, 750mg and 1000mg Prolonged-release Tablets

PL: Parallel Imports from the Italian market

Active Ingredient: metformin hydrochloride

Manufactured by

Bruno Farmaceutici SpA, Italy

Distribution and Batch Information

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

Background

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.

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.

Additional information:

For further medical information enquiries please contact: info@bruno.org

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

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07

Updates to this page

Published 20 February 2025
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