Class II · Moderate risk Terminated
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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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.
Class II · Moderate risk Terminated
Erythromycin Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Film 4mg/1mg 30 Pouches…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vraylar
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Rectiv
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Namzaric
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Linzess
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Restasis 0.05%30x 0.4ml Opth Pf
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ubrelvy 100mg 10ud Cplt
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vaniqa
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Bromfenac Ophthalmic Solution 0.09% 1.7ml Ndc/Upc 62332-508-17
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Metoprolol Tartrate and Hydrochlorothiazide Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Cosopt
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Atropine Sulfate Ophthalmic Solution
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Lidocaine HCL Visc 2% 100ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ofloxacin 0.3% 5ml Opth
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Fenofibrate Capsules
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.