Class 4 Medicines Defect Notification: Fresenius Medical Care Deutschland GmbH, balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis, EL(26)A/24
Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label.
DMRC reference number
DMRC - 39439934
Marketing Authorisation Holder
Fresenius Medical Care Deutschland GmbH
Medicine Details
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.
Advice for 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.
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 share this with Nephrologists & Renal Nurse practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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