Class II · Moderate risk
Capecitabine Tablets
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
HydrOXYzine Hydrochloride Tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class III · Low risk
Metoclopramide Oral Solution
Defective Container: Lids on unit dose cups are not fully qualified.
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIH-Hydroxyprogesterone Caproate 250
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phentolamine 5 mg/mL in Normal Saline
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 500 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/20 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/2/20 Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 20/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 6/0.33/3.33 Injection Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 17/0.6/5.7 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 20 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phent .8/PGE1 20 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Papav/Phentol 30/.5 mg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Papav/Phent 30/1 mg Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Papav/Phentol 30/1 mg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Papav/Phent 24/1 mg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..