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,

FDA recall notice · announced September 14, 2016 · Isomeric Pharmacy Solution

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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,

Reason for recall

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.

Notes

Distribution: Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
Lot/code information: Lots# 03045 and 03046; Exp. 10/16
Quantity: 274 multdose vials
Status: Terminated
Products in this recall event:
- 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, (D-1480-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.