Ulsal lösliche Tabletten
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 that below mentioned batches may contain an impurity called N-nitrosodimethylamine (NDMA).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) and therefore "Ulsal 300 mg lösliche Tabletten" are recalled as a precautionary measure.
Other Ulsal products (Ulsal Brausetabletten, Ulsal Filmtabletten, Ulsal Ampullen) are not affected by the recall at the moment.
Please see further information on the BASG-website referring to "Review ranitidine medicines following detection of NDMA".
| Name of the medicinal product | Ulsal 300 mg lösliche Tabletten |
|---|---|
| Marketing authorisation number(s) | 1-19711 |
| Marketing authorisation holder | Gebro Pharma GmbH |
| Batch number(s) | PZN: 3509690 Arzneispezialität: Ulsal 300 mg lösliche Tabletten (10 Stück Packung) Chargen: 170002732 PZN: 3509709 Arzneispezialität: Ulsal 300 mg lösliche Tabletten (30 Stück Packung) Chargen: 170002734, 170002837 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2984 |
Further inquiry note
Page last modified:
07/11/2019