Drug Products Recall

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

Contact:
Actavis Inc.
Sarita Thapar, PharmD
Tel: 908-659-2471
Media Inquiries
Actavis Group
Hjordis Arnadottir
354-535-2300 / 840 7476
E-mail: harnadottir@actavis.com

FOR IMMEDIATE RELEASE — Morristown, NJ, August 1, 2008 — Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The inspection at Little Falls revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices.  Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.

This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk.  If patients should wish to obtain replacement medications and/or prescription, they should contact their health care professional or pharmacist.   For more information regarding this market action, please visit www.actavis.us/RecallFAQ.

Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI.

Actavis Totowa, LLC is a United States subsidiary of Actavis Group hf.  This voluntary action is limited only to the Actavis Totowa products manufactured in the Little Falls, NJ facility listed below.  Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other facilities are thus not impacted by this recall

Answers to frequently asked questions regarding this market action can be found on www.actavis.us/RecallFAQ.

FDA Warns Consumers of Counterfeit Presciption Drugs

FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
Expired and suspected counterfeit prescription drugs found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include:

• Lisinopril (20 milligrams)
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
• Gabapentin (100 mg, 300 mg and 400 mg)
• Metoprolol (50 mg)
• Nifedipine (30 mg)
• Diclofenac Sodium (30 mg)
• Glucophage (500 mg Extended Release)
• Glucovance (125 mg and 500 mg)
• Glipizide/Metformin (2.50 mg/250 mg)
• Furosemide (20 mg)
• Tamoxifen Citrate (10 mg)
• Metformin HCl ER (500 mg)
• Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.