Reason: Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
Distributed: Nationwide and CanadaReason: Lack of Assurance of Sterility: All compounded products.
Distributed: US: New EnglandReason: Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Distributed: NationwideReason: Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Distributed: Nationwide Foreign: Israel, TaiwanReason: Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Distributed: Nationwide.Reason: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Distributed: Nationwide.Reason: Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Distributed: NationwideReason: Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Distributed: NationwideReason: Subpotent; 6 month stability time point
Distributed: NationwideReason: Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Distributed: Nationwide