June 2012 FDA Recall Drug by Stat Rx Usa
D-050-2013 - Labeling

This Class III drug recall was voluntarily initiated by Stat Rx Usa on June 18, 2012 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in FL, PA, and VA. and the recall is currently terminated.

Recall Number: D-050-2013

Reason for Recall
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Initiated
06-18-2012
Reported
11-21-2012
Quantity
22 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62940
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.
Stat Rx USA
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, PA, and VA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-31-2013
Product Description About Product Description
Full technical description of the product.
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

Batch or Lot Expiration Information

Lot# Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14