Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.
DMRC Number: DMRC - 39439934
Company name:Fresenius Medical Care Deutschland GmbH
Product description:
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) |
Details of the affected batch:
| 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 information:
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 to 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.
Advice 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.
Company contacts for further 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.
To access the full recall/alert: