Class II · Moderate risk Terminated
Refresh Tears
Reason Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Estradiol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estradiol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estrone
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estriol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Alka-Seltzer Gold
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
Alka-Seltzer Extra Strength
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
Alka-Seltzer Original
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
hCG Body Shaper
Reason Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Class II · Moderate risk Terminated
Nystatin and Triamcinolone Acetonide Cream
Reason Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class II · Moderate risk Terminated
Levonorgestrel Non-Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Ethinyl Estradiol Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Testosterone Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estrone Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estriol Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estradiol Non-Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estradiol Micronized Bulk
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Ongoing
Ventolin HFA
Reason Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk Terminated
Latanoprost Ophthalmic Solution
Reason Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class II · Moderate risk Terminated
Kalbitor
Reason Presence of Particulate Matter: Glass