Zantac Brausetabletten
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 that "Zantac Brausetabletten" may contain 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. Zantac 150 mg - Brausetabletten 2. Zantac 300 mg - Brausetabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-19710 2. 1-19712 |
| Marketing authorisation holder | GlaxoSmithKline Pharma GmbH |
| Batch number(s) | PZN: 2479320 Arzneispezialität: Zantac 150 mg - Brausetabletten (20 Stück Packung) Charge: 170019298 PZN: 2479337 Arzneispezialität: Zantac 150 mg - Brausetabletten (50 Stück Packung) Charge: 170010387, 170004912 PZN: 2479343 Arzneispezialität: Zantac 300 mg - Brausetabletten (10 Stück Packung) Charge: 180004449, 1601609101 PZN: Arzneispezialität: Charge: PZN: 2479366 Arzneispezialität: Zantac 300 mg - Brausetabletten (30 Stück Packung) Charge: 180012086, 180002870, 1601685601, 1601685501 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2982 |
Further inquiry note
Page last modified:
07/11/2019