Class II · Moderate risk
Alka-Seltzer Original
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
hCG Body Shaper
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
Nystatin and Triamcinolone Acetonide Cream
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class II · Moderate risk
Levonorgestrel Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Ethinyl Estradiol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Testosterone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estrone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Micronized Bulk
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Latanoprost Ophthalmic Solution
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class II · Moderate risk
Kalbitor (ecallantide)
Presence of Particulate Matter: Glass
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications; 9 month long term stability
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Cotellic (cobimetinib)
Superpotent Drug: An oversized tablet was found in a bottle.
Class II · Moderate risk
Metronidazole Injection
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Levofloxacin Injection in 5% Dextrose
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.