Class II · Moderate risk
Rectiv (nitroglycerin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Linzess (linaclotide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Restasis 0.05%30x 0.4ml Opth Pf
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ubrelvy 100mg 10ud Cplt
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vaniqa (eflornithine hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09% 1.7ml Ndc/Upc 62332-508-17
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Metoprolol Tartrate and Hydrochlorothiazide Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Lidocaine HCL Visc 2% 100ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ofloxacin 0.3% 5ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Methocarbamol 500mg 500
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synthroid (levothyroxine sodium tablets, USP)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Creon (pancrelipase)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Niacin 250mg 110
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Therapeutic M 130
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ganirelix Acetate Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
ZOMA-Jet 10 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
ZOMA-Jet 5 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.