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
FDA Drug Recalls
390 recalls · Class II, newest first
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
Morphine Sulfate USP Milled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class II · Moderate risk
SyrSpend SF Suspending Base
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Class II · Moderate risk
Earth's Care Eczema Lotion
Microbial Contamination of Non-Sterile Products.
Class II · Moderate risk
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class II · Moderate risk
Maximum Strength Zephrex-D
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Doctor Manzanilla Cough & Cold
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Doctor Manzanilla Allergy & Decongestant Relief
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Choice Antibacterial Hand Soap
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk
Mild Healthcare Antibacterial Hand Soap
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk
Option Systems Antibacterial Foaming Hand Wash
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Class II · Moderate risk
Ninjacof-A
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg)
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk
Rugby Aller-chlor
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Senexon Liquid Natural Vegetable Stimulant
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Diocto Syrup
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Diocto Liquid
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Senexon Liquid Natural Vegetable Stimulant
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Aller-chlor
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Major Senna Syrup Natural Vegetable Laxative
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination