Class II · Moderate risk
Benzefoam Emollient Foam Benzoyl Peroxide 5.3% 100gm Top Emol NDC 187-0194--10
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Lotemax Sm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nuedexta (dextromethorphan HBr and quinidine sulfate)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eszopiclone 3mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ondansetron HCL 4mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amoxicillin 500mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eletriptan Hydrobromide Tablets 20 mg* 6
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ibuprofen Oral Suspension USP 100mg/5ml 120ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapagliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapgliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Gemcitabine Injection 200mg/5.26ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Edarbi (azilsartan medoxomil)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Enoxaparin Dofium Injrvyion
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Travoprost Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 4mg/1mg 30 Pouches…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vraylar (cariprazine)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.