Product: 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, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Reason for recall: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Recall initiated: 20260121
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated