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 recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-2967

Further inquiry note