Class II · Moderate risk Terminated
SIU-Tri-Mix 30/1/10 Injection
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
SIU-Tri-Mix 24/1/20 Injection
Reason 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 Terminated
SIU-Tri-Mix 20/1 mg/10 mcg/mL
Reason 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 Terminated
SIU-Tri-Mix 18/1/10 Injection
Reason 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 Terminated
SIU-Tri-Mix 6/0.33/3.33 Injection Solution
Reason 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 Terminated
SIU-Tri-Mix 18/1/20 Injection
Reason 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 Terminated
SIU-Tri-Mix 17/0.6/5.7 Injectable
Reason 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 Terminated
SIU-Prostaglandin E1 20 mcg/mL Injection
Reason 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 Terminated
SIU-Phent .8/PGE1 20 mcg/mL Inj.
Reason 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 Terminated
SIU-Papav/Phentol 30/.5 mg/mL Injection
Reason 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 Terminated
SIU-Papav/Phent 30/1 mg Inj.
Reason 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 Terminated
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection
Reason 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 Terminated
SIU-Papav/Phentol 30/1 mg/mL Injection
Reason 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 Terminated
SIU-Papav/Phent 24/1 mg/mL Inj.
Reason 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 Terminated
SIU-Papaverine 30 mg/mL Inj.
Reason 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 Terminated
SIH-Testosterone Cyp. 20 mg/mL Injection
Reason 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 Terminated
S-methylcobalamin 25 mg/mL
Reason 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 Terminated
SIH-Testosterone Cyp. 200 mg/mL Injection
Reason 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 Terminated
S-Chorionic Gonad HCG 1000 U/mL Injection
Reason 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 Terminated
S-Methylcobalamin 1000 mcg/mL
Reason 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 Terminated
Absorica
Reason Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Class II · Moderate risk Terminated
c-Budesonide 0.6MG capsules
Reason Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Class II · Moderate risk Terminated
Methylcobalamin 1
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk Terminated
Lidocaine/Sodium Chloride 0.4%/20% Injectable
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.