Last week, Sun Pharmaceutical Industries had the positive news that the FDA had cleared two of its Caraco subsidiary plants to again sell products in the U.S. This week, Sun and the FDA said Sun is recalling a drug marketed by Caraco Pharmaceutical Laboratories because of potential health dangers.
According to the FDA release, Sun is voluntarily recalling one lot of Nimodipine Capsules, 30 mg, which are used to decrease problems due to bleeding in the brain. The recall came after a customer complained that there were crystals of nimodipine in the solution.
There have been no reports of adverse events, and the FDA says the clinical health implications of the crystals is unknown. But the agency warned that the crystals might mean the product is no longer "bioequivalent and may potentially affect patients who are being treated for a medical emergency."
Last week, Sun said that two Michigan plants have been given permission to again manufacture two products, heart drug Carvedilol and antibiotic Paromomycin. Three years ago, the plants had so many manufacturing and recall problems that the FDA sent in U.S. marshals to quarantine products.
The Indian drugmaker cautioned investors last week that "Caraco is required to now work with an external auditor conducting regular inspections for an extended period," and said additional revenue from the plants would accrue slowly.
- here's the recall announcement
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