June 2016 FDA Recall Drug by Valeant Pharmaceuticals North America Llc
D-1059-2016 - Labeling

This Class III drug recall was voluntarily initiated by Valeant Pharmaceuticals North America Llc on June 10, 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-1059-2016

Reason for Recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Initiated
06-10-2016
Reported
07-06-2016
Quantity
958 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74532
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.
Valeant Pharmaceuticals North America 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.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2017
Product Description About Product Description
Full technical description of the product.
SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.

Batch or Lot Expiration Information

Lot# : 2555979, Expiry: 09/2016.