Class II · Moderate risk Terminated
Cyclosporin liquid 1%
Reason Lack of sterility assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Vitamin B12 liquid 1000mcg/ml
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Testosteron Cypionate liquid 200mg/ml
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Methocarbamol liquid 100mg/ml
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine/Epinepherine liquid 1%/ 1:1000
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine gel 2%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Hydroxyprogesterone liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
HCG liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Epinephrine liquid 1:1000
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 2%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk Terminated
0.9% Buffered Lidocaine HCl
Reason Subpotent
Class II · Moderate risk Terminated
Cidofovir Injection 375mg/5mL
Reason Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class II · Moderate risk Terminated
Dianeal Low Calcium
Reason Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts
Reason Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class II · Moderate risk Terminated
Nitrofurantoin Oral Suspension
Reason Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Class II · Moderate risk Terminated
Oxygen
Reason CGMP Deviations
Class II · Moderate risk Terminated
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Cidofovir Dihydrate
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk Terminated
Folic Acid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Zinc Sulfate
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glycyrrhizic Acid
Reason Lack of sterility assurance.