Lupin’s US arm - Lupin Pharmaceuticals Inc (collectively Lupin) is recalling 12,480 bottles of Paroxetine extended-release tablets in the strength of 12.5 mg from the US market. The said tablets have been manufactured by the company at its Pithampur plant in Madhya Pradesh. The product is used for treatment of depression, panic disorder and social anxiety disorder.
As per the United States Food and Drug Administration (USFDA), the ongoing voluntary nationwide in the USA recall is a class III recall. The reason for the recall is ‘failed dissolution specifications: out of specification observed in dissolution testing at 3 month long term stability study’.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1839.85 |
| Dr. Reddys Lab | 1293.00 |
| Cipla | 1340.75 |
| Zydus Lifesciences | 940.00 |
| Lupin | 2344.95 |
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