The Compounding Pharmacy of Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 recall — FDA D-1677-2015
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Complete FDA and NHTSA recall records dated in September 2015.
These records include useful source details for the selected month.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Defective Container: There were customer complaints of cracked and leaking glass vials.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability…
Failed Stability Specifications: product may not meet specification limit for assay test.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
CocoNoNut CACAO-NECTAR BAR because it may contain undeclared almond.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.