August 2014 FDA Recall Drug by Alvogen, Inc
D-1607-2014 - Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.

This Class II drug recall was voluntarily initiated by Alvogen, Inc on August 28, 2014 for the product Drug. The FDA reported the reason for recall as failed content uniformity specifications - the lot failed to meet the acceptance criteria for uniformity of dosage units at the time of release for the oxycodone component.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1607-2014

Reason for Recall
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Initiated
08-28-2014
Reported
10-01-2014
Quantity
8,964 (100 Count) bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69159
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.
Alvogen, Inc
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-30-2015
Product Description About Product Description
Full technical description of the product.
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.

Batch or Lot Expiration Information

Lot# NDC #47781-0230-01
Lot# 453289; Exp 08/31/15