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When using Ozempic or Rybelsus tablets concomitantly with other oral drugs that have a narrow therapeutic index or that require clinical monitoring, consider increased clinical or laboratory monitoring Use in Specific Populations Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Arya, M., Levison, J., Giordano, T

In the warning letter, FDA includes several repeat observations from 2022, including discoloration on equipment in the ISO 5 area, monitoring environmental conditions in aseptic processing areas, and failure to establish and follow appropriate written procedures to prevent microbiological contamination

Cold or room-temperature dinners (like the tuna bowl or cottage cheese plate) bypass this entirely