Unichem Pharmaceuticals recalled Bisoprolol Fumarate and Hydrochlorothiazide tablets on January 21, 2026. The recall affects tablets that do not meet impurity specifications for N-Nitroso Bisoprolol. Consumers should stop using the product and contact their healthcare provider immediately.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Consumers and healthcare providers should stop using this product immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for guidance. Notification method: Letter
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The recall involves Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, in 100-count bottles. These tablets are prescribed only and were manufactured by Unichem Laboratoris Ltd. The affected lot number is GBHL24005A with an expiration date of September 2026.
The recall was initiated due to deviations from current Good Manufacturing Practices (cGMP). Specifically, the tablets did not meet the N-Nitroso Bisoprolol impurity specification limits, which poses a significant health risk.
There have been no specific injury or incident reports associated with this recall as of now. However, the impurity risk is classified as high, indicating potential serious health consequences.
Stop using the recalled tablets immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for further guidance. Consumers will receive notification via letter regarding the recall.
For more information, consumers can reach Unichem Pharmaceuticals USA Inc. at [contact number not provided]. Additional details are available on the FDA website.
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