Class I - Dangerous
Failed Excipient Specifications: high content of ethylene glycol (EG)
VistaPharm
Class I - Dangerous
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class I - Dangerous
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class I - Dangerous
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class I - Dangerous
Failed Stability Specifications
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class I - Dangerous
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class I - Dangerous
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Defective Container: Leakage of unit dose cups that may occur at the seal.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Class I - Dangerous
Defective Container: Lids on unit dose cups are not fully qualified.
Class I - Dangerous
Defective Container: Product leaks when inverted.
Class I - Dangerous
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Class I - Dangerous
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Class I - Dangerous
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Class I - Dangerous
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Class I - Dangerous
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Impurities/Degradation Products: exceeded specification at 3 month stability testing