Medicine recalls
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| The United States: Padagis issues voluntary nationwide recall for Nitroglycerin Lingual Spray due to a possible defective delivery system |
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The US Food and Drug Administration (FDA) announces that Padagis US LLC has issued a voluntary nationwide recall to the consumer/user level of 3 lots of Nitroglycerin Lingual Spray 400mcg per spray (lot number: 150892, 153199, 156041). Out of an abundance of caution, this product is being recalled from the market due to a complaint received that a unit may not dispense. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of the dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.
If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.
All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12g bottle contained within a carton.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/padagis-issues-voluntary-nationwide-recall-nitroglycerin-lingual-spray-due-possible-defective
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Dec 28, 2021
Issued at HKT 15:00
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