Hydal retard

Recall | Medicines | 14/05/2019

The marketing authorisation holder informed its customers on May 13, 2019 that overweight capsules may be packed and distributed to the market. The patient risk arising from a single overfill capsule is very low in Austria. Nevertheless a risk to patients cannot be excluded and below mentioned four batches are recalled as a precautionary measure.



Name of the medicinal product Hydal retard 24 mg Kapseln
Marketing authorisation number(s) 1-21978
Marketing authorisation holder Mundipharma Gesellschaft mbH
Batch number(s) 0010107755 (10 Stück Packung),
0010107754 (30 Stück Packung),
0010000863 (30 Stück Packung),
0010000862 (30 Stück Packung)
Classification of the recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-2840

Further inquiry note