Recalls / Class II
Class IID-0536-2021
Product
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark
- Brand name
- Ozempic
- Generic name
- Oral Semaglutide
- Active ingredient
- Semaglutide
- Route
- Oral
- NDCs
- 0169-1704, 0169-1715, 0169-1709, 0169-4303, 0169-4307, 0169-4314, 0169-4815, 0169-4804, 0169-4809
- FDA application
- NDA213051
- Affected lot / code info
- K082347
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Novo Nordisk
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 1189 cartons
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0536-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.