Ranitidin ratiopharm
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 "ratiopharm" 150 mg –Filmtabletten 2. Ranitidin "ratiopharm" 300 mg – Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-24240 2. 1-24241 |
| Marketing authorisation holder | Teva B.V. |
| Batch number(s) | PZN: 2428357 Arzneispezialität: Ranitidin "ratiopharm" 150 mg - Filmtabletten (20 Stück Packung) Charge: U02855F, U30266A PZN: 2428363 Arzneispezialität: Ranitidin "ratiopharm" 150 mg - Filmtabletten (50 Stück Packung) Charge: U08356A, V00866D PZN: 2428386 Arzneispezialität: Ranitidin "ratiopharm" 300 mg -Filmtabletten (10 Stück Packung) Charge: U09527C PZN: 2428392 Arzneispezialität: Ranitidin "ratiopharm" 300 mg - Filmtabletten (30 Stück Packung) Charge: T27910A, U09527A, U25430A, V00999A |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2969 |
Further inquiry note
Page last modified:
07/11/2019