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

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

DMRC Number: DMRC- 38673150

Company name:Bayer Plc

Product description: Gastrografin gastroenteral solution

PL: 00010/0537

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 9757711000001100

Details of the affected batch:

Product description: Urografin 150 Infusion

PL: 00010/0568

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

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

Details of the affected batch:

Product description: Urografin 150 Injection

PL: 00010/0569

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

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

Details of the affected batch:

Background information: 

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 to 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.

Company contacts for further information: 

For all medical information enquiries and information on this product, please email medical.information@bayer.co.uk, or telephone 0118 206 3116.

For stock control enquiries please email orders-uk@bayer.com, or telephone 0118 206 3131.

To access the full recall/alert: 

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