Drugs Recalls

Lack of Assurance of Sterility: Leaking/damaged syringes.

CGMP Deviations

Lack of Assurance of Sterility: Leaking/damaged syringes.

cGMP deviations

CGMP Deviations

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Lack of Assurance of Sterility: Media fill with bacterial contamination

CGMP Deviations

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations