Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class II · Moderate risk Terminated
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL
Reason Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class III · Low risk Terminated
Enalapril Maleate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Enalapril Maleate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Rocaltrol
Reason Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk Terminated
Calcitriol Oral Solution
Reason Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class II · Moderate risk Terminated
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 16 mg
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 4 mg
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Fentanyl
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Fentanyl
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Morphine Sulfate 1 mg/mL
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class III · Low risk Terminated
Equate ClearLAX
Reason Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Class II · Moderate risk Terminated
PHENYLephrine 10 mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Lack of Assurance of Sterility: Potential leakage of bags.