Warning
Unichem Pharmaceuticals USA Inc. Recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0301-2026Drug / Pharmaceutical
Unichem Pharmaceuticals USA Inc. Recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets
Unichem Pharmaceuticals USA Inc. · Class II — Moderate Risk
Product Description
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide and PR.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database