Lidocaine gel 1%, RX, plastic dropper
Hiers Enterprises, LLC
Lack of sterility assurance.
Prescription and over-the-counter medications
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Amerigen Pharmaceuticals
Failed Dissolution Specifications
Failed Dissolution Specifications
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Asclemed USA Inc.
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Sub-potent
CBI Laboratories
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.