MHRA Class 4 Medicines Defect Notification: balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis (Fresenius Medical Care Deutschland GmbH)
MHRA Class 4 Medicines Defect Notification: balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis (Fresenius Medical Care Deutschland GmbH)
DMRC reference number: DMRC- 39439934
Date issued: 14 May 2026
Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.
Marketing Authorisation Holder: Fresenius Medical Care Deutschland GmbH
Medicine Details
Product name: balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
PL: 13689/0013
Active ingredient: In 1 litre ready-to-use solution:
- Calcium chloride dihydrate – 0.1838g
- Sodium chloride – 5.640g
- Sodium (S) lactate solution (sodium (S) lactate) – 7.85g (3.925g)
- Magnesium chloride hexahydrate – 0.1017g
- Glucose monohydrate (anhydrous glucose) – 25.0g (22.73g)
SNOMED code: N/A
GTIN:4046241132298
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| F4LM071 | 11/2026 | 2 x 5ltr bags | 04/02/2025 |
| G4LB133 | 01/2027 | 2 x 5ltr bags | 01/07/2025 |
| G4LL144 | 10/2027 | 2 x 5ltr bags | 26/01/2026 |
| G4LM152 | 11/2027 | 2 x 5ltr bags | 23/02/2026 |
| H4LB212 | 11/2028 | 2 x 5ltr bags | 07/05/2026 |
| G4LI151 | 08/2027 | 2 x 5ltr bags | 26/01/2026 |
Background
Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label. The Braille message on the balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis, incorrectly states ‘CAPD/DPCA 19’. All other label information and printed data are correct for all above listed batches.
| Product | Issue |
| balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis | Braile message incorrectly states ‘CAPD/DPCA 19 |
Correct Braille message balance 2.3% Glucose, 1.25 mmol/l calcium
Advice for healthcare professionals
There is no product quality issue, the affected batches will not be recalled. Where necessary, healthcare professionals should explain the Braille text error to patients who depend solely on braille for reading medicine packaging.
View the full alert here.
Advice for Healthcare Professionals to Provide to Patients:
Patients can continue using solution bags from the above batches, and no further action is required. Any required support or guidance will be provided by the relevant healthcare professionals.
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 MHRA Yellow Card scheme.
Additional information:
For all medical information enquiries and information on this product, please email Medinfo-UK@freseniusmedicalcare.com, or telephone 01623 445 215. For stock control enquiries please email ukorders@freseniusmedicalcare.com, or telephone 01623 445 100.
