Class II · Moderate risk
Lidocaine gel 2%
Lack of sterility assurance.
FDA Drug Recalls
1,586 recalls · Class II, newest first
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.