Class II · Moderate risk
Rompe Pecho EX Expectorant
Microbial Contamination of Non-Sterile Products
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
Rompe Pecho CF Cold & Flu with Honey
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Ethacrynate Sodium for Injection
cGMP Deviations
Class II · Moderate risk
Glycopyrrolate Tabs
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Class II · Moderate risk
Kushim Tablets
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Olmesartan Medoxomil Tablets 20 mg
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Class II · Moderate risk
Walgreens Acne Cleansing Bar
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
Class II · Moderate risk
Zinc Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate/Progesterone Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility