April 2014 FDA Recall Drug by Legacy Pharmaceutical Packaging
D-1363-2014 - Correct Labeled Product Miscart/Mispack

This Class II drug recall was voluntarily initiated by Legacy Pharmaceutical Packaging on April 9, 2014 for the product Drug. The FDA reported the reason for recall as correct labeled product miscart/mispack. The product was distributed in IN and the recall is currently terminated.

Recall Number: D-1363-2014

Reason for Recall
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Initiated
04-09-2014
Reported
06-18-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67978
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.
Legacy Pharmaceutical Packaging
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2017
Product Description About Product Description
Full technical description of the product.
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61

Batch or Lot Expiration Information

Lot# No lot or expiration date is displayed on this carton.