MHRA 发布 Bristol Laboratories 苯氧甲基青霉素 250 mg/5ml 口服溶液二级召回 EL(26)A/33

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP
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-40025785

Marketing Authorisation Holder

Bristol Laboratories Limited

Medicine Details

Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP

PL: 17907/0249

Active ingredient: phenoxymethylpenicillin potassium

SNOMED code: 21039011000001101

GTIN: 05060013943225

Affected Lot Batch Numbers

Background

Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues. The outer carton is correctly labelled as Phenoxymethylpenicillin Oral Solution 250 mg/5 mL, however, the bottle contained within some cartons may be labelled as Phenoxymethylpenicillin Oral Solution 125 mg/5 mL.  The preliminary investigation indicates that this issue is not widespread, however further investigations are ongoing.

Bristol Laboratories Limited have confirmed 5420 packs have been distributed (supplied within UK to approved distributors between 29 April 2026 to 28 May 2026) and the remaining 13296 packs remain on hold and will not be distributed further.

Advice for Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

• If batch/product traceability information is available, pharmacy professionals and other healthcare professionals involved in dispensing should identify and immediately contact all patients who have been dispensed the impacted product and ask them to confirm if details on the carton and label and ensure that this matches the dispensing label.

• If batch/product traceability information is not available, pharmacists should identify all patients dispensed this product from 29 April 2026 onwards. Where appropriate and feasible, contact all patients who have been dispensed the impacted product with priority given to those who have been dispensed the product most recently and within the last 7 days (the majority of these products will have been reconstituted by the dispensing pharmacy prior to administration by the patient).

• If any patients are identified with this product, pharmacy professionals and other healthcare professionals involved in dispensing should contact the patients’ GP, or healthcare professional responsible for the care of the patient, to discuss treatment review and whether a new prescription is required for ongoing resupply.

Advice for Patients:

If you have been prescribed Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP and have received impacted product (Batch Number 7124002, Expiry Date 11/2026), please check that the label on the bottle matches the dispensing label. If the label on the bottle does not match the dispensing label contact the pharmacy where your product was dispensed.

If you have any concerns, please contact your pharmacy for more information and advice.  Patients should continue to take medicines from these batches as prescribed by your healthcare professional. Whilst this issue has been highlighted in some cartons, it is unlikely to be widespread across the entire batch, therefore if you have already used the medicine, there is no need to take further action unless side effects are experienced.

The most important side-effect of medicines containing penicillin is hypersensitivity (an allergic reaction) and patients will normally be reviewed for this prior to prescribing and dispensing of this medicine. Patients and carers should be aware the main side effects to this medicine are diarrhoea; allergic reactions; nausea; skin reactions; thrombocytopenia; vomiting.

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 medical information enquiries please contact: [email protected]

For stock control enquiries please contact: [email protected]

Recipients of this Medicines Recall 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.

Yours faithfully

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: Bristol Laboratories Limited, Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP, EL(26)A/33