Class II · Moderate risk
Albuterol 0.083% Inh Sol. 30 days supply
Lack of Processing Controls.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL
Lack of Processing Controls.
Class II · Moderate risk
WipeEssentials Wet Wipes
CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk
Acure
CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk
Amantadine HCl Capsules
Failed Dissolution Specifications
Class II · Moderate risk
PASTA DE LASSAR ANDROMACO Skin Protection
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Zhong Hua Jiu
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Class III · Low risk
24-HOUR Oral Care q4 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
24-HOUR Oral Care q2 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class II · Moderate risk
Conzerol (antipoxin)
cGMP Deviations
Class II · Moderate risk
Molleave
cGMP Deviations
Class II · Moderate risk
Conzerol zero molluscum contagiosum
cGMP Deviations
Class II · Moderate risk
Levofloxacin in 5% Dextrose Injection
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
Levofloxacin in 5% Dextrose Injection
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
Levetiracetam in 0.54% Sodium Chloride Injection
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
Levetiracetam in 0.75% Sodium Chloride Injection
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
Levetiracetam in 0.82% Sodium Chloride Injection
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
Levofloxacin in 5% Dextrose Injection
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
Linezolid Injection 600 mg per 300 mL
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
Lupin Cefdinir powder for Oral Suspension USP
Superpotent Drug
Class II · Moderate risk
Testosterone/Finasteride 80 mg/8 mg pellet
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 55 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 50 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol 40 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.