Information on Drug Recall, Market Withdrawals, and Safety Alerts for Providers

Gateway Health Plan® is committed to giving health care providers important information to help you coordinate safe and quality drug therapy for your patients. To support you in these efforts, we are providing you with tools to keep you informed of drug recalls, market withdrawals, and safety alerts.

The Food and Drug Administration (FDA) posts information on drug products that have been recalled due to manufacturing problems and/or safety concerns. For up-to-date information on drug recalls, market withdrawals, and safety alerts, visit the FDA website at: http://www.fda.gov/Safety/MedWatch/default.htm.

In addition, the FDA publishes its weekly Drug Enforcement Report which contains information on actions taken in connection with agency regulatory activities. The Drug Enforcement Report can be accessed via the following link: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

Drug Recalls have three categories according to the level of hazard involved. Recalls may be conducted voluntarily by a manufacturer, by FDA request, or by FDA order under statutory authority.

• Class I recall: a situation in which use of or exposure to a violative product will cause serious adverse health consequences or death.
• Class II recall: 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.
• Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

How to Report an Adverse Event to the FDA:

By phone: 1-800-332-1088
By Fax: 1-800-FDA-0178
Online: Reporting forms can be accessed on the FDA website at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Source: http://www.fda.gov/

• Date received 11/19/10
  FDA recommends all healthcare professionals stop prescribing and dispensing propoxyphene-containing products due to new data showing that the drug can cause serious toxicity to the heart, such as prolonged PR interval, widened QRS complex and prolonged QT interval, even when used at therapeutic doses.
  Questions about this recall, call the FDA at 1-800-332-1088.

• Date received 9/29/10
  Octapharma USA, Inc. is initiating a voluntary market withdrawal of ALL lots of Octagam 5% Liquid Preparation until a root cause of the previously reported thromboembolic events can be determined and the problem corrected.

  If you have any questions about this market withdrawal you should contact Octapharma’s customer service department at 866-766-4860.

• Date Received 1/21/2010
  Endo Pharmaceuticals will discontinue the sale and distribution of all available strengths of Moban^® (molindone) Tablets. This action is not the result of any issues with safety or efficacy. Endo has been unable to obtain an alternate supplier of molindone hydrochloride after the current supplier notified Endo of their intent to discontinue manufacture of molindone hydrochloride. Supplies are expected to be depleted by June 30, 2010.

  Questions regarding this discontinuation should contact Endo Pharmaceuticals at 1-800-462-3636.