Class II · Moderate risk Terminated
Levonorgestrel Non-Micronized
Reason cGMP Deviations; lack of quality assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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 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
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications; 9 month long term stability
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Oral Suspension
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Cotellic
Reason Superpotent Drug: An oversized tablet was found in a bottle.
Class II · Moderate risk Terminated
Metronidazole Injection
Reason 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 Terminated
Levofloxacin Injection in 5% Dextrose
Reason 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 Terminated
Fluconazole Injection
Reason 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 Terminated
Ciprofloxacin in Dextrose
Reason 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 Terminated
hydrALAZINE HYDROCHLORIDE INJECTION
Reason Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Class II · Moderate risk Terminated
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
ATENOLOL Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.