Class II · Moderate risk Terminated
Cephalexin for Oral Suspension USP
Reason CGMP Deviation; manufacturing batch record could not be located
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
Vecuronium Bromide for Injection 20 mg* *1mg/mL when…
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk Terminated
Vecuronium Bromide for Injection 10 mg*
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class II · Moderate risk Terminated
Lidocaine gel 1%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 0.05%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 0.2%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 0.5%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 1%
Reason Lack of sterility assurance.
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.