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Undeclared Sulfites in product
Subpotent Drug: Assay below the approved specification
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Product may be contaminated with spoilage organisms.
Defective container; blister packaging inadequately sealed.
Products contains Magnesium Salicylate.
contaminated with Bacillus cereus and may be spoiled
Review of Label determined allergen was listed as unsalted butter/ heavy cream. In one instance of identified label, there was no milk or dairy listed listed in Contains statement. Further review of label revealed "soy" had been removed.
Undeclared milk
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).