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 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
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| MA04HM9 | 02/2028 | 10x100ml | 01/05/2024 |
| MA04JKA | 03/2028 | 10x100ml | 31/05/2024 |
| MA04KFC | 04/2028 | 10x100ml | 30/07/2024 |
| MA04KJ9 | 04/2028 | 10x100ml | 01/08/2024 |
| MA04M60 | 07/2028 | 10x100ml | 23/09/2024 |
| MA04MLL | 08/2028 | 10x100ml | 04/11/2024 |
| MA04MM9 | 09/2028 | 10x100ml | 15/12/2024 |
| MA04MN9 | 09/2028 | 10x100ml | 19/01/2025 |
| MA04NDU | 10/2028 | 10x100ml | 13/02/2025 |
| MA04NNB | 11/2028 | 10x100ml | 06/03/2025 |
| MA04PJL | 12/2028 | 10x100ml | 15/04/2025 |
| MA04PLZ | 12/2028 | 10x100ml | 29/05/2025 |
| MA04PMV | 01/2029 | 10x100ml | 11/07/2025 |
| MA04RL2 | 02/2029 | 10x100ml | 14/08/2025 |
| MA04RL3 | 02/2029 | 10x100ml | 15/09/2025 |
| MA04S6C | 02/2029 | 10x100ml | 30/10/2025 |
| MA04S6B | 02/2029 | 10x100ml | 03/10/2025 |
| MA04S6T | 02/2029 | 10x100ml | 02/12/2025 |
| MA04XJ8 | 07/2029 | 10x100ml | 09/01/2026 |
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
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| MA044UD | 03/2026 | 1x250ml | 09/02/2023 |
| MA04A58 | 03/2026 | 1x250ml | 27/06/2023 |
| MA04BVD | 07/2026 | 1x250ml | 09/11/2023 |
| MA04BVE | 07/2026 | 1x250ml | 23/01/2024 |
| MA04HS8 | 02/2029 | 1x250ml | 04/06/2024 |
| MA04L2M | 02/2029 | 1x250ml | 18/07/2024 |
| MA04LTC | 05/2029 | 1x250ml | 27/08/2024 |
| MA04NAL | 07/2029 | 1x250ml | 11/12/2024 |
| MA04MK6 | 08/2029 | 1x250ml | 19/11/2024 |
| MA04SJ3 | 09/2029 | 1x250ml | 03/07/2025 |
| MA04NB8 | 10/2029 | 1x250ml | 23/04/2025 |
| MA04UXS | 10/2029 | 1x250ml | 15/10/2025 |
| MA04VPT | 05/2030 | 1x250ml | 12/01/2026 |
| MA042CN | 05/2026 | 1x500ml | 24/06/2022 |
| MA044U4 | 05/2026 | 1x500ml | 01/11/2022 |
| MA048LU | 05/2026 | 1x500ml | 09/03/2023 |
| MA04BV0 | 05/2026 | 1x500ml | 26/07/2023 |
| MA04FRU | 05/2026 | 1x500ml | 12/03/2024 |
| MA044U9 | 07/2026 | 1x500ml | 02/03/2023 |
| MA04TLV | 03/2030 | 1x500ml | 29/07/2025 |
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
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| MA042JA | 06/2026 | 10x10ml | 28/07/2022 |
| MA046UT | 06/2026 | 10x10ml | 19/12/2022 |
| MA0496X | 06/2026 | 10x10ml | 29/03/2023 |
| MA04AP0 | 06/2026 | 10x10ml | 08/08/2023 |
| MA04BX7 | 06/2026 | 10x10ml | 27/10/2023 |
| MA04FHP | 06/2026 | 10x10ml | 13/06/2024 |
| MA04KJB | 06/2026 | 10x10ml | 15/08/2024 |
| MA04L45 | 06/2026 | 10x10ml | 15/09/2024 |
| MA04S8T | 02/2030 | 10x10ml | 17/06/2025 |
| MA043T7 | 09/2026 | 10x20ml | 13/09/2022 |
| MA046TS | 09/2026 | 10x20ml | 20/02/2023 |
| MA0497C | 09/2026 | 10x20ml | 21/03/2023 |
| MA04R4R | 09/2029 | 10x20ml | 25/04/2025 |
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 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.
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
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