FDA recall D-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

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Key facts

Status

Terminated

Initiation date

2021-03-15

Report date

2021-06-02

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0536-2021