Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
FDA Drug Recalls
560 recalls, newest first
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class II · Moderate risk
CLEVIPREX (clevidipine injectable emulsion)
Lack of Assurance of Sterility
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
Class I · High risk
Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class III · Low risk
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Class III · Low risk
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Presence of Foreign Tablets/Capsules