Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
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 Presence of Particulate Matter: Hair was found in products
Reason Presence of Particulate Matter: Hair was found in products
Reason Presence of Particulate Matter: Hair was found in products
Reason Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Reason Lack of Assurance of Sterility
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