Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing…
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Reason Failed Dissolution Specifications
Reason Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary…
Reason Lack of sterility assurance
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