PlainRecalls
FDA Drug Moderate Class II Terminated

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,

Reported: September 14, 2016 Initiated: June 29, 2016 #D-1480-2016

Product Description

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.

Details

Units Affected
274 multdose vials
Distribution
Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
Location
Salt Lake City, UT

Frequently Asked Questions

What product 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,. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 274 multdose vials.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 14, 2016. Severity: Moderate. Recall number: D-1480-2016.