Ranitidin STADA
Recall
|
Medicines
|
24/10/2019
The marketing authorisation holder informed its customers on October 24, 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 Stada 150 mg Filmtabletten 2. Ranitidin Stada 300 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-22432 2. 1-22433 |
| Marketing authorisation holder | STADA Arzneimittel GmbH |
| Batch number(s) | PZN: 2426430 Arzneispezialität: Ranitidin Stada 150 mg Filmtabletten (20 Stück Packung) Chargen: 75032-A, 71420-A PZN: 2426447 Arzneispezialität: Ranitidin Stada 150 mg Filmtabletten (50 Stück Packung) Chargen: 75032, 71420 PZN: 2426453 Arzneispezialität: Ranitidin Stada 300 mg Filmtabletten (10 Stück Packung) Chargen: 75037-A, 75037-B PZN: 2426476 Arzneispezialität: Ranitidin Stada 300 mg Filmtabletten (30 Stück Packung) Chargen: 90550, 75037, 71426 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2985 |
