Zydus Pharmaceuticals USA Inc is recalling over 16 thousand bottles of Bupropion Hydrochloride tablets manufactured by Ahmedabad-based Cadila Healthcare on account of failure to meet the desired dissolution specifications. Zydus Pharmaceuticals USA Inc is the US arm of Zydus Cadila’s listed entity Cadila Healthcare.
Around 16,356 bottles of Bupropion Hydrochloride extended release tablets in the strength of 300 mg are being recalled. As per the latest Enforcement Report of the United States Food & Drug Administration (USFDA), the voluntary ongoing nationwide recall is a class III recall. A class III recall is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. It is the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1807.25 |
| Dr. Reddys Lab | 1273.80 |
| Cipla | 1388.80 |
| Zydus Lifesciences | 1104.35 |
| Lupin | 2292.00 |
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