Isomeric Pharmacy Solution, LLC recalls Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by…

Recall date

June 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1480-2016

FDA classification

Class II

Brand / firm

Isomeric Pharmacy Solution, LLC

Sold / distributed

Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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,