Alembic Pharmaceuticals’ US-based subsidiary is recalling 82,400 bottles of Tobramycin Ophthalmic Solution in the American market. Tobramycin Ophthalmic Solution is used to treat bacterial infections of the eye.
New Jersey-based Alembic Pharmaceuticals Inc is recalling the affected lot (0.3 per cent, 5ml bottle) due to ‘Failed Impurities/Degradation Specifications’. The company initiated the Class III voluntary recall on July 27 this year. As per USFDA, 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’.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1872.40 |
| Dr. Reddys Lab | 1279.70 |
| Cipla | 1304.70 |
| Zydus Lifesciences | 956.65 |
| Lupin | 2245.65 |
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