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
Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.
1,002 FDA drug recalls with this cause, newest first.
These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.
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 I · High risk
Levofloxacin in 5% Dextrose Injection
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Class II · Moderate risk
Earth's Care Eczema Lotion
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Linezolid Injection 600 mg/300 mL
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
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
Class II · Moderate risk
Rugby Diocto Syrup
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
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