Articles related to PRODUCT RECALL

“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.” — FDA Class II Recall Definition

Use of the affected products may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.

Thrombotic events occurred earlier with Andexxa than usual care (median of 3.5 days vs 16 days). Fifty-three percent of Andexxa-treated patients who experienced a thrombotic event had the event during the first 3 days.

The FDA’s Class II designation indicates that exposure or usage of ‘a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.’

The recall encompasses three dosages for prazosin hydrochloride capsules: 181K+ bottles of 1-milligram doses, 291K+ bottles of 2-milligram doses, and 107K+ bottles of 5-milligram doses, all distributed nationwide.

The FDA says on its website that it has been investigating drugs for nitrosamines in some types of medications, noting they’re common in water and foods. But the agency noted that such impurities have been linked to an increase in cancer in individuals who are exposed to elevated levels and over long periods of time.