Class 2 Medicines Recall: Baxter Healthcare Limited, Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml, EL(25)A/46
Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons labelled as Hartmann’s Solution may contain Ringer’s Solution 1000mL.
DMRC reference number
DMRC-36821405
Marketing Authorisation Holder
Baxter Healthcare Ltd
Medicine Details
Compound Sodium Lactate Solution for Infusion BP (Hartmann’s Solution for infusion) in Viaflo 1000ml
PL: 00116/0330
Active ingredient: potassium chloride, sodium chloride, sodium lactate, calcium chloride dihydrate
SNOMED code: 17208011000001109
GTIN: 05413760142524 (Unit), 55413760142529 (Carton)
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 25C11T3B | 29/2/2028 | 1000 ml | 28/4/2025 |
Background
Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons within this batch labelled as Hartmann’s Solution may contain Ringer’s Solution 1000mL. This means the wrong product may be inside the box (mixed product in carton).
Advice for Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
Baxter Healthcare Ltd can confirm 55,340 packs of this batch have been released and distributed. No related adverse event reports or product quality complaints have been received related to this defect.
Advice for Patients:
No further action is required by patients as this is at Pharmacy and Wholesaler level. 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 all medical information enquiries and information on this product, please email Medinfo_UKI@baxter.com, or telephone 0800 0260514.
For stock control enquiries please email victoria_franklin@baxter.com, or telephone +44 07825 374866.
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.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London E14 4PU
Telephone +44 (0)20 3080 6574
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