Overview of recall records associated with VistaPharm, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 21, Class III: 6.
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
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
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.
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.
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.
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.
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
This page summarizes recall records in which the official source identifies VistaPharm, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
