bisoprolol fumarate and hydrochlorothiazide

2 recalls on record

Jan 21

U

Unichem Pharmaceuticals USA Inc. — Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate,

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

FDAHealth

Nov 21

G

Glenmark Pharmaceuticals Inc., USA — Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-0

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

FDAHealth