June 2016 FDA Recall Drug by Isomeric Pharmacy Solution, Llc
D-1480-2016 - Lack of Processing Controls

This Class II drug recall was voluntarily initiated by Isomeric Pharmacy Solution, Llc on June 29, 2016 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1480-2016

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.
Initiated
06-29-2016
Reported
09-14-2016
Quantity
274 multdose vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74603
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Isomeric Pharmacy Solution, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of 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,

Batch or Lot Expiration Information

Lot# Lots# 03045 and 03046; Exp. 10/16