Unichem Pharmaceuticals USA Inc. Recall: Bisoprolol Fumarate and Hydrochlorothiazide table
Unichem Pharmaceuticals USA Inc. Recall: Bisoprolol Fumarate and Hydrochlorothiazide table is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Unichem Pharmaceuticals USA Inc.; Product: Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Man
| Recalling firm | Unichem Pharmaceuticals USA Inc. |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide and PR. |
| Recall initiated | 20260121 |
| Recall number | D-0301-2026 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
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