Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
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 I · High risk
SinuCleanse Soft Tip NETI POT Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
SinuCleanse Premixed SALINE PACKETS
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
Atovaquone Oral Suspension
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class II · Moderate risk
Vivier Sheer SPF 30 Mineral With Antioxidants
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Barrier Therapy Skin Protectant Cream
Microbial contamination of non-sterile Products -
Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk
Oatmeal Daily Moisturizing Body Lotion
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class I · High risk
STELLALIFE VEGA Oral Care
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class I · High risk
suntegrity
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class II · Moderate risk
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class I · High risk
Atovaquone Oral Suspension USP
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class II · Moderate risk
Febuxostat Tablets 80mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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