Class II · Moderate risk
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
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.