January 2013 FDA Recall Drug by Stat Rx Usa
D-144-2013 - Labeling

This Class III drug recall was voluntarily initiated by Stat Rx Usa on January 28, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-144-2013

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Initiated
01-28-2013
Reported
02-13-2013
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64223
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-06-2013
Product Description About Product Description
Full technical description of the product.
Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.

Batch or Lot Expiration Information

Lot# A02568, Exp 01/16