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Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains...

FDA Recall #D-0523-2021 — Class II — March 15, 2021

Recall #D-0523-2021 Date: March 15, 2021 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Cardinal Health Inc. — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

299 cartons

Distribution

FL, GA, SC

Code Information

1778598

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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