Ranitidin 1A Pharma, Ranic Hexal
Recall
|
Medicines
|
17/09/2019
The marketing authorisation holder informed its customers on September 16, 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 1A Pharma 300 mg –Filmtabletten 2. Ranic Hexal 150 mg – Filmtabletten 3 Ranic Hexal 300 mg – Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-22308 2. 1-23133 3. 1-23150 |
| Marketing authorisation holder | 1. 1A Pharma GmbH 2. Hexal Pharma GmbH 3. Hexal Pharma GmbH |
| Batch number(s) | 1. GH7122, HY8294, FA8465, FG8960, FP7904, FX4777, FY2892, GT6029, GY6275, HN8231, HY8292, JR6922 2. FL1894, GC0445, GG4033, HF7413, JF5814, FB1364, FF3575, FP1378, FY7863, GC0443, GG4030, GL1454, GW3419, HF7415, HW0843, JC5224, JU7248, JU7252 3. FA8464, FX4780, GL6339, HH4324, JJ7113, FB9981, FM5399, FP7912, FU3554, GA5053, GF6553, GL6329, GT4706, GU5257, HA9599, HN8232, HR9198, JF4647, JR8004 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2967 |
Further inquiry note
Page last modified:
07/11/2019