February 2016 FDA Recall Drug by Isomeric Pharmacy Solution, Llc
D-0728-2016 - Labeling

This Class III drug recall was voluntarily initiated by Isomeric Pharmacy Solution, Llc on February 2, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0728-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.
Initiated
02-02-2016
Reported
03-02-2016
Quantity
114 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73207
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-03-2016
Product Description About Product Description
Full technical description of the product.
Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109

Batch or Lot Expiration Information

Lot# Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015"