Class II · Moderate risk
Cyclosporin liquid 0.05%
Lack of sterility assurance.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Cyclosporin liquid 0.2%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.5%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 1%
Lack of sterility assurance.
Class II · Moderate risk
Vitamin B12 liquid 1000mcg/ml
Lack of sterility assurance.
Class II · Moderate risk
Testosteron Cypionate liquid 200mg/ml
Lack of sterility assurance.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.
Class II · Moderate risk
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine/Epinepherine liquid 1%/ 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine gel 2%
Lack of sterility assurance.
Class II · Moderate risk
Hydroxyprogesterone liquid
Lack of sterility assurance.
Class II · Moderate risk
HCG liquid
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Epinephrine liquid 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 2%
Lack of sterility assurance.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk
0.9% Buffered Lidocaine HCl
Subpotent
Class II · Moderate risk
Cidofovir Injection 375mg/5mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Class II · Moderate risk
Oxygen
CGMP Deviations
Class II · Moderate risk
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Failed dissolution specifications
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.