Medicine recalls
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| The United States: Azurity Pharmaceuticals, Inc. issues voluntary nationwide recall of one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/ml Kit, due to a mix-up of the diluent included in the kit |
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The US Food and Drug Administration (FDA) announces that Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/ml Kit (lot number: 21035) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.
Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection. To date, Azurity has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-one-lot-firvanqr-vancomycin
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Sep 9, 2021
Issued at HKT 14:00
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