Class II · Moderate risk Terminated
Steglatro
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Belsomra
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Belsomra
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Pedia-Lax 66ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Carbidopa and Levordopa Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vitamin D3 50mcg 100 Calc
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Benzoyl Peroxide Wash 5% 148ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28gm
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vitamin D3 25mcg 180 Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vitamin D3 25mcg 90 Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vitamin D3 50mcg 100 Softgels
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Acne Medication Benzoyl Peroxide Gel USP
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Miconazole 7 2% 45gm Apl
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Trazodone Hydrochloride Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Tri-Lo-Marzia 0.180mg/0.025mg
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Siladryl 12.5/5ml 118ml Sf Af
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ferrous Sulfate 75 mg
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Phentermine HCL 37.5mg 100 C4
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Phentermine HCL 30mg 100 C4
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Livalo
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.