Class II · Moderate risk Terminated
Belbuca
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Belbuca
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Dexameth Sod Phos 0.1% 5ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Tobramy/Dex 0.3-0.1% 10ml Opth
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Muro-128 2% 15ml Opth
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Benzefoam Emollient Foam Benzoyl Peroxide 5.3% 100gm Top Emol NDC 187-0194--10
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Lotemax Sm
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Nuedexta
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Eszopiclone 3mg 100 C4
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ondansetron HCL 4mg 30
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Amoxicillin 500mg 100
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Eletriptan Hydrobromide Tablets 20 mg* 6
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP 100mg/5ml 120ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
xigduo XR
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
xigduo XR
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Bevespi Aerosphere
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Gemcitabine Injection 200mg/5.26ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Edarbi
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Timolol Maleate Ophthalmic Solution
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Enoxaparin Dofium Injrvyion
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Travoprost Ophthalmic Solution
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.