October 2013 FDA Recall Drug by Sandoz, Inc
D-66458-1 - Cross contamination with other products

This Class II drug recall was voluntarily initiated by Sandoz, Inc on October 9, 2013 for the product Drug. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-66458-1

Reason for Recall
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Initiated
10-09-2013
Reported
11-13-2013
Quantity
692 bottles (90 count)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66458
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.
Sandoz, 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.
07-07-2014
Product Description About Product Description
Full technical description of the product.
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92

Batch or Lot Expiration Information

Lot# Lot DJ2744, Exp 12/2014