Drug recall D-0523-2021
Product
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
1778598
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 299 cartons
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Belsomra – drug information
- NDC 0006-0325 Belsomra · Suvorexant 15 mg/1 · Merck Sharp & Dohme LLC
- NDC 0006-0005 Belsomra · Suvorexant 5 mg/1 · Merck Sharp & Dohme LLC
- NDC 0006-0033 Belsomra · Suvorexant 10 mg/1 · Merck Sharp & Dohme LLC
- NDC 0006-0335 Belsomra · Suvorexant 20 mg/1 · Merck Sharp & Dohme LLC