Class II · Moderate risk
Vaniqa (eflornithine hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
11,818 recalls · Class II, newest first
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.
Class II · Moderate risk
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk
Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class II · Moderate risk
Nortriptyline HCL capsules
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.