June 2013 FDA Recall Prednisone by Boehringer Ingelheim Roxane Inc
D-882-2013 - Labeling
This Class III drug recall was voluntarily initiated by Boehringer Ingelheim Roxane Inc on June 14, 2013 for the product Prednisone. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-882-2013
Labeling: Missing Label; missing label on blister card
06-14-2013
08-21-2013
14,619 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
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.
General area of initial distribution.
Nationwide
06-23-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Batch or Lot Expiration Information
Lot# The affected product consists of
Lot# 261739A, expiration date OCT 2014.
