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
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 21, 2026 |
| Reported | February 11, 2026 |
| Recalling firm | Unichem Pharmaceuticals USA Inc. |
| Country / region | United States NJ |
Hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Affected products
- Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Est
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