Class II · Moderate risk Terminated
Potassium Phosphate
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Quelicin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Cyclobenzaprine HCl Tablets
Reason Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Class II · Moderate risk Terminated
Amantadine HCl Capsules
Reason Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Class II · Moderate risk Terminated
Succinylcholine Chloride
Reason Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Class II · Moderate risk Terminated
Ibuprofen Tablets
Reason Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate Oral Solution
Reason Defective container: Oral solution leaking from container.
Class II · Moderate risk Terminated
Neut Sodium Bicarbonate 4%
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Inj.
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Potassium Phosphates Inj.
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
CVS Health Baby Eczema Moisturizing Cream
Reason Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Class II · Moderate risk Terminated
Magnesium Citrate Saline Laxative Cherry Flavored
Reason Presence of foreign substance: glass particle
Class II · Moderate risk Terminated
NitroGlycerin
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
NitroGlycerin
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
VenomX
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.