Ranitidin Accord
Recall
|
Medicines
|
26/09/2019
The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) and therefore below mentioned medicinal products are recalled as a precautionary measure.
Please see further information on the BASG-website referring to "Review ranitidine medicines following detection of NDMA".
| Name of the medicinal product | 1. Ranitidin Accord 150 mg Filmtabletten 2. Ranitidin Accord 300 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-31865 2. 1-31866 |
| Marketing authorisation holder | Accord Healthcare B.V. |
| Batch number(s) | PZN: 4204283 Arzneispezialität: Ranitidin Accord 150 mg Filmtabletten (30 Stück Packung) Charge: PT04702 PZN: 4204320 Arzneispezialität: Ranitidin Accord 300 mg Filmtabletten (30 Stück Packung) Charge: PX01010 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2983 |
Further inquiry note
Page last modified:
07/11/2019