Incorrect/Undeclared Excipients.
Vi-Jon
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
CGMP Deviations
CGMP Deviations;
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
CGMP Deviations
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Cross Contamination: Presence of IPA in finished product.
Failed Stability Specifications
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Presence of foreign substance: glass particle
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.