Lupin’s arm -- Lupin Pharmaceuticals Inc. is recalling 6,16,506 bottles of Ramipril capsules, a medication indicated for high blood pressure in the US due to deviation from current good manufacturing practices (CGMP). The company is recalling 1,12,770 bottles of 2.5 mg tablets; 1,46,322 bottles of 5 mg tablets and 3,57,414 bottles of 10 mg tablets. The affected lot is manufactured at Lupin's Goa-based manufacturing facility.
The company is undertaking Class II voluntary recall due to CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1862.15 |
| Dr. Reddys Labs. | 1350.00 |
| Cipla | 1440.30 |
| Zydus Lifesciences | 1101.50 |
| Lupin | 2342.15 |
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