October 27, 2017
Unichem Pharmaceuticals USA Inc. is recalling 30-count bottles of bisoprolol fumarate tablets, 5 mg (NDC 29300-126-13), according to the October 25, 2017, US Food and Drug Administration (FDA) Enforcement Report. During stability testing, the tablets were out of specification for an unknown impurity.
More than 96,000 bottles from 3 lots are included in the recall: lots GBOL16001 and GBOL16002 (Exp. 12/31/2017), and lot GBOL16015 (Exp. 3/31/2018). The bottles were distributed nationwide.
Carotid Implant Promising For Resistant Hypertension
Renal denervation may lower BP in some people with untreated hypertension
Unichem Pharmaceuticals issued the voluntary recall October 2, 2017, and the FDA designated it Class II October 18, 2017. The classification suggests use of the affected product could cause temporary or reversible adverse effects, with a remote likelihood of serious harm.
Available with a prescription, bisoprolol fumarate is a beta blocker used to treat high blood pressure.