MHRA 发布 Baxter Healthcare 复方乳酸钠输注液 1000ml 二级召回（EL(25)A/46）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Patients
8. Additional information
9. Download document

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

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 [email protected], or telephone 0800 0260514. 

For stock control enquiries please email [email protected], 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 

[email protected]

Download document

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