FDAMarch 15, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What to do

FDA enforcement status: Terminated

Brands named

cardinal healthcardinal

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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