FDA-Drug2025-08-20Class II
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
Merck & Co. Inc
Hazard
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Sold states
Nationwide in the USA and PR.
Affected count
51,320 cartons
Manufactured in
126 E Lincoln Ave, N/A, Rahway, NJ, United States
Products
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2025Don't want to check this manually?
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