Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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
Mesalamine Delayed-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 120mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 80 mg
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
Cinacalcet Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Quality Choice No Drip Severe Congestion Nasal Pump Mist
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk
Premier Value Tussin Cough DM
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class I · High risk
Robitussin Honey CF Max Nighttime Adult
Microbial Contamination of Non-Sterile Products
Class I · High risk
Robitussin Honey CF Max Non-Drowsy Adult
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
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 Grape Flavor 10 fl. oz
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk
Good Neighbor Pharmacy
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class I · High risk
VITRAKVI (larotractenib)
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class I · High risk
Sucralfate Oral Suspension
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class II · Moderate risk
Restore Sinus Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
ION* Sinus Support Nasal Spray
Microbial contamination of Non-Sterile Products
Class I · High risk
ION*Sinus Spray
Microbial contamination of Non-Sterile Products
Class I · High risk
TheraBreath for Kids! Oral Rinse
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
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