Ulsal Brausetabletten, Filmtabletten, Ampullen
Recall
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Medicines
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20/11/2019
The marketing authorisation holder informed its customers on November 20, 2019 that a review of ranitidine medicines after tests showed that below mentioned marketing authorisations 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 Brausetabletten, Filmtabletten and Ampullen 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. Ulsal 150 mg Brausetabletten 2. Ulsal 300 mg Brausetabletten 3. Ulsal 150 mg - Filmtabletten 4. Ulsal 300 mg - Filmtabletten 5. Ulsal 50 mg/2 ml – Ampullen |
|---|---|
| Marketing authorisation number(s) | 1. 1-19713 2. 1-19711 3. 1-17368 4. 1-18559 5. 1-17369 |
| Marketing authorisation holder | Gebro Pharma GmbH |
| Batch number(s) | 1. 181831, 191594, 181830, 181832, 181833, 190888A, 190888B, 190889A, 190890A 2. 182878, 182878C, 192301, 182878B, 182878D, 182879, 182879A, 182880, 182880A, 182881, 182881A, 182882, 182882A 3. 1700577, 1800188, 1900175, 1900470, 1902431, 1700578, 1800189, 1900176 4. 1700180, 1700580, 1801763, 1700181, 1700579, 1700697, 1801764, 1801765, 1901167 5. 71219D, 80723B, 90111A Anmerkung: Eine Übersichtsliste der betroffenen Chargen inklusive Pharmazentralnummern (PZN) wird separat veröffentlicht. |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2984 |
Further inquiry note
Page last modified:
20/11/2019