Class II · Moderate risk Terminated
Potassium Phosphate
Reason Lack of Assurance of Sterility
FDA Drug Recalls
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Class II · Moderate risk Terminated
Quelicin
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
MAN OF STEEL capsules
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
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 III · Low risk Terminated
Amitriptyline HCl Tablets
Reason Cross Contamination With Other Product: Imipramine
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 III · Low risk Terminated
Gaviscon
Reason Superpotent Drug: high out-of-specification result for magnesium.
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.