Class II · Moderate risk Terminated
Albuterol 0.083% Inh Sol. 30 days supply
Reason Lack of Processing Controls.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
WipeEssentials Wet Wipes
Reason CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk Terminated
Acure
Reason CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk Terminated
Amantadine HCl Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
PASTA DE LASSAR ANDROMACO Skin Protection
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Zhong Hua Jiu
Reason CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Class III · Low risk Terminated
24-HOUR Oral Care q4 Kit with Ballard* Technology
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
24-HOUR Oral Care q2 Kit with Ballard* Technology
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
Chlorhexidine Gluconate Oral Rinse
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class II · Moderate risk Terminated
Conzerol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Molleave
Reason cGMP Deviations
Class II · Moderate risk Terminated
Conzerol zero molluscum contagiosum
Reason cGMP Deviations
Class II · Moderate risk Terminated
Levofloxacin in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levofloxacin in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levetiracetam in 0.54% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levetiracetam in 0.75% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levetiracetam in 0.82% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levofloxacin in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Linezolid Injection 600 mg per 300 mL
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Lupin Cefdinir powder for Oral Suspension USP
Reason Superpotent Drug
Class II · Moderate risk Terminated
Testosterone/Finasteride 80 mg/8 mg pellet
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Estradiol 55 mg
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Estradiol 50 mg
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Estradiol 40 mg
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.