Class II · Moderate risk
Lidocaine HCL Visc 2% 100ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
1,058 recalls, newest first
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 I · High risk
Durisan Antimicrobial Solutions
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Class I · High risk
Durisan Antimicrobial Solutions
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Class I · High risk
heal the world
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class III · Low risk
Tremfya (guselkumab)
Temperature Abuse
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 III · Low risk
Romidepsin Injecton
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Class I · High risk
Acetaminophen
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.