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December 28, 2021December 27, 2021 – Padagis US LLC has recalled three lots of nitroglycerin lingual spray due to a possible defect in the delivery system. Nitroglycerin lingual spray is indicated for use in adults to provide acute relief from or to prevent chest pain caused by coronary artery disease.
- There is no impact to members through Benecard Central Fill.
- The affected product is packaged in 12g spray bottles. If the spray bottle does not dispense sufficient medication, there is a risk of continued chest pain. The drug's label advises patients to seek prompt medical attention if they do not experience chest pain relief after taking three doses over the course of 15 minutes. As of the recall date, Padagis had not received any reports of adverse events related to the affected product.
- Padagis is instructing patients in possession of the recalled spray to discontinue use and contact their healthcare provider for an alternate replacement before returning the product. For return instructions or help with questions about the recall, patients should contact Sedgwick at 1-888- 266-7912 or padagis5665@sedgwick.com. If a patient has experienced problems that may be related to use of the recalled product, Padagis recommends they contact their healthcare provider.
- A full copy of the recall announcement can be found on the FDA's website.