Drug product
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)
D-0584-2025
Product summary
- Firm
- Merck & Co. Inc
- Event
- Event 97254
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51,320 cartons
- Official record key
drug-enforcement:D-0584-2025
Official wording
Reason: 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.
Code information: Lots 2090019 and 2123744, Exp. 4/30/2027
Distribution pattern: Nationwide in the USA and PR.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications