Class II · Moderate risk Terminated
MORphine 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Midazolam 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
MAGnesium 4gm in NS 100 mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
HYDROmorphone 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Heparin 25
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine 50mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
0.2% ROPivacaine - OnQ Pump
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Monsel's Solution
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class III · Low risk Terminated
TESTOSTERONE 200 mg PELLET
Reason Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk Terminated
ESTRADIOL 20mg PELLET
Reason Labeling: Incorrect or Missing Lot and/or Exp Date.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class III · Low risk Terminated
Maxzide-25
Reason Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc99m Medronate
Reason Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk Terminated
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Reason Superpotent and Subpotent
Class I · High risk Terminated
Naloxone Hydrochloride Injection
Reason Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.