MHRA 就 Bayer 的 Gastrografin 与 Urografin 150 发布 Class 3 药品召回 EL(26)A/12

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Gastrografin gastroenteral solution
4. Affected Lot Batch Numbers
5. Medicine Details
   1. Urografin 150 Infusion
6. Affected Lot Batch Numbers
7. Medicine Details
   1. Urografin 150 Injection
8. Affected Lot Batch Numbers
9. Background
10. Advice for Healthcare Professionals
11. Advice for Healthcare Professionals to Provide to Patients
12. Additional information
13. Download document

DMRC reference number

DMRC- 38673150

Marketing Authorisation Holder

Bayer Plc

Medicine Details

Gastrografin gastroenteral solution

PL: 00010/0537

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 9757711000001100

GTIN: 5016703008323

Affected Lot Batch Numbers

Medicine Details

Urografin 150 Infusion

PL: 00010/0568

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 8058511000001109 (250 ml 8058911000001102 (500 ml)

GTIN: 5016703000013 (250 ml) 5016703000983 (500 ml)

Affected Lot Batch Numbers

Medicine Details

Urografin 150 Injection

PL: 00010/0569

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 8057711000001100 (10 ml) 8058111000001100 (20 ml)

GTIN: 5016703000860 (10 ml) 5016703000976 (20 ml)

Affected Lot Batch Numbers

Background

Bayer Plc is recalling all stock of the above products as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and wholesaler level.

Advice for Healthcare Professionals:

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

Advice for Healthcare Professionals to Provide to Patients:

No action is required by patients. The medication is administered by healthcare professionals for use during radiological examinations. The recall is at the wholesaler and pharmacy level.

The products are being recalled out of an abundance of caution, no reports of patient harm have been received from patients relating to this defect.

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 [email protected], or telephone 0118 206 3116.

For stock control enquiries please email [email protected], or telephone 0118 206 3131.

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]

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Class 3 Medicines Recall: Bayer Plc, Various Products, EL(26)A/12