Prescription and over-the-counter medications
GlaxoSmithKline Consumer Healthcare Holdings
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Denver Solutions, LLC
Labeling: Not Elsewhere Classified
Biomic Sciences, LLC
Microbial contamination of Non-Sterile Products
Denver Solutions, LLC
Labeling: Not Elsewhere Classified
Biomic Sciences, LLC
Microbial contamination of Non-Sterile Products
Denver Solutions, LLC
Labeling: Not Elsewhere Classified
Biomic Sciences, LLC
Microbial contamination of Non-Sterile Products
West-Ward Columbus
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Lack of Assurance of Sterility
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Lack of Assurance of Sterility
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Pine Pharmaceuticals
Lack of Assurance of Sterility