2021-09-01 · Class II · Terminated
D-0773-2021 · Eli Lilly & Company
Dulaglutide · Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Open attributed report →FDA enforcement report year
2021 FDA peptide enforcement reports
5 dated reports mapped only through exact reviewed application-number annotations.
2021-06-02 · Class II · Terminated
D-0417-2021 · Cardinal Health Inc.
Linaclotide · CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Open attributed report →2021-06-02 · Class II · Terminated
D-0536-2021 · Cardinal Health Inc.
Semaglutide · CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Open attributed report →2021-04-21 · Class II · Terminated
D-0618-2021 · Novo Nordisk Inc
Liraglutide · Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Open attributed report →2021-04-21 · Class II · Terminated
D-0622-2021 · Novo Nordisk Inc
Liraglutide · Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Open attributed report →