class 3

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

Added

Author

Cathy

Categories

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.

DMRC Number: DMRC-34710077

Company name: Bruno Farmaceutici SpA, Italy

Product descriptions: 

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 recall document

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 recall document

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 recall document

Brief description of 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 to 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 to 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.

Company contacts for further information:

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

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