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BELSOMRA (SUVOREXANT)
Wed Aug 20 2025
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Reason for Recall
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.
Manufacturers
| Drug | Manufacturer |
|---|---|
| BELSOMRA (SUVOREXANT) | Merck Sharp & Dohme LLC |
Number of affected units
51,320 cartons
Distribution pattern
Nationwide in the USA and PR.
UPCs
Info not provided.
Package NDCs
| NDC |
|---|
| 0006-0005-10 |
| 0006-0005-30 |
| 0006-0005-13 |
| 0006-0033-10 |
| 0006-0033-30 |
| 0006-0033-13 |
| 0006-0325-10 |
| 0006-0325-30 |
| 0006-0325-13 |
| 0006-0335-10 |
| 0006-0335-30 |
| 0006-0335-13 |
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