Medicine recalls
|
| |
| The United Kingdom: Class 3 Medicines Recall: Bayer Plc, various products |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Bayer Plc is recalling all stock of the following products containing meglumine amidotrizoate and sodium amidotrizoate as a precautionary measure due to the identification of an impurity above the acceptable limit:
- Gastrografin gastroenteral solution (pack size: 10x100ml)
- Urografin 150 Infusion (pack size: 1x250ml and 1x500ml)
- Urografin 150 Injection (pack size: 10x10ml and 10x20ml)
The recall is at pharmacy and wholesaler level. For details of the affected batch numbers of the products, please refer to the MHRA website.
Gastrografin is a contrast medium for the radiological examination of the gastrointestinal tract while Urografin is X-ray contrast medium for the delineation of the vascular and renal systems.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-bayer-plc-various-products-el-26-a-slash-12
In Hong Kong, Urografin 150 Infusion and Urografin 150 Injection are not registered pharmaceutical products, while Gastrografin Liq Oral/Rectal (HK-46076) is a pharmaceutical product registered by Bayer Healthcare Limited (Bayer) and is an over-the-counter medicine. As confirmed by Bayer, the affected batches of Gastrografin recalled in the above United Kingdom announcement have not been imported into Hong Kong.
On 24 Feb 2026, the Department of Health (DH) endorsed Bayer to recall a total of 5 batches of Gastrografin Liq Oral/Rectal (HK-46076) (batch number: MA04HF2-H1, MA04MPR-H1, MA04MPR-H2, MA04P3R-H1, MA04S8L-H1) from the market as a precautionary measure due to the presence of impurity (N-Nitroso-Meglumine) in the product. A recall statement was issued by DH and was posted on the Drug Office website on the same date. Related news was previously issued by Macao Pharmaceutical Administration Bureau and Singapore Health Sciences Authority, and was posted on the Drug Office website on 25 Feb 2026 and 3 Mar 2026 respectively.
Ends/Friday, Mar 13, 2026
Issued at HKT 16:15
|
| |
|
