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Failed Dissolution Specifications
Superpotent; Hydrochlorothiazide
Superpotent Drug: Minimally superpotent
Superpotent Drug
Lack of sterility assurance: bag has the potential to leak.
Undeclared fish allergen
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Defective container: Out of specification for container integrity leading to bottles leaking.
Complaint led investigation found the presence of Bacillus Cereus in one lot of product.
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Product Mix-up
Subpotent Drug
Lack of Assurance of Sterility
Temperature Abuse; temperature excursion during shipping
Product bottle has potential to become pressurized over time. When consumer opens a bottle, the cap, capsules, and product powder could be forcefully expelled, and customers may sustain injuries to their hands and eyes.
Failed Impurities/Degradation Specifications