Class II · Moderate risk Terminated
Cosopt
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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.
Class II · Moderate risk Terminated
Methocarbamol 500mg 500
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Synthroid
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Creon
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Niacin 250mg 110
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Therapeutic M 130
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ganirelix Acetate Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
ZOMA-Jet 10 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
ZOMA-Jet 5 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
Omeprazole Delayed-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk Terminated
Durisan Antimicrobial Solutions
Reason 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 Terminated
Durisan Antimicrobial Solutions
Reason 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 Terminated
0.9% SODIUM CHLORIDE Irrigation
Reason Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk Terminated
Gabapentin Oral Solution
Reason Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class II · Moderate risk Terminated
Nortriptyline HCL capsules
Reason 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.
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Reason Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II · Moderate risk Terminated
Progesterone Capsules
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel.