To date, the Company has not received any reports of adverse events related to this recall.
Safety Alerts and Recalls
The Agency assessed the risk of severe hypocalcemia in 2 studies and through a review of cases.
A preliminary evaluation of available evidence does not suggest a causal link between GLP-1 RAs and suicidal thoughts or actions.
The recalled IV bags were distributed nationwide to hospitals.
The Agency has seized thousands of units of the counterfeit product and is currently testing it, along with manufacturer Novo Nordisk.
These products were manufactured in June 2023 and distributed primarily in June, July, and August 2023.
To date, the Company has not received reports of any adverse events related to this recall.
The affected product was identified to have a low level of benzene, a human carcinogen, following a recent review by the manufacturer and their third party laboratory.
The recalled products were distributed nationwide to wholesalers, hospitals, and institutions in the United States and Puerto Rico from March 14, 2023 to June 29, 2023.
According to the FDA safety alert, health care professionals are recommended to administer promethazine hydrochloride injection via deep IM administration to reduce the risk of severe tissue injury.
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