The Compounding Pharmacy of Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 recall — FDA D-1672-2015
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Complete FDA and NHTSA recall records dated in 2015, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
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.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Potential for adulteration - elevated mold, yeast, and coliform counts
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.