Class II · Moderate risk Terminated
Ibuprofen Tablets
Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Ibuprofen Tablets
Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class I · High risk Terminated
MAGnesium 2 gm in NS 100 mL Magnesium SULfate
Reason Subpotent
Class I · High risk Terminated
Clopidogrel Tablets
Reason LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Class II · Moderate risk Terminated
Lovastatin Tablets USP
Reason Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Class I · High risk Terminated
Ampicillin and Sulbactam for Injection 1.5 g vial
Reason Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Class II · Moderate risk Terminated
Earth's Care Eczema Lotion
Reason Microbial Contamination of Non-Sterile Products.
Class II · Moderate risk Terminated
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Rocuronium Bromide in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Methadone HCl Injection in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Meperidine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Esmolol HCl in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vecuronium Bromide in Sterile Water for Injection in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Neostigmine Methylsulfate Injection in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Labetalol HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Nicardipine HCl in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl Injection in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
HYDROmorphone HCl in 5% Dextrose in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Atropine Sulfate Injection in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glycopyrrolate in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ketamine HCl Injection in all strengths
Reason Lack of sterility assurance.