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Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.


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


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

Amantadine 100mg capsulesMeperidine & Promethazine capsules
Amibid DM ER tabletsMeperidine HCl 100 mg and 50 mg tablets
Amibid DM tabletsMethenamine Mandelate 0.5 g and 1.0 g tablets
Amidrine capsulesMirtazapine 15 mg, 30 mg, and 45 mg tablets
Amigesic 500 mg caplets and 750 mg capletsMirtazapine OD tablets, 15 mg, 30 mg and 45 mg
Amitex PSE tabletsMulti-ret Folic 500 mg tablets
Bellamine S tabletsMulti-vita-bets 0.5 mg and 1.0 mg FL & FE tablets
Betaxolol 10 mg and 20 mg tablets USPMulti-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets
Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tabletsNaltrexone 50mg tablets
Carisoprodol & Aspirin tabletsOxycodone & Acetaminophen 5/500mg capsules
Carisoprodol, Aspirin & Codeine tabletsOxycodone HCl 5 mg, 15 mg and 30 mg tablets
Carisoprodol 350mg tabletsOxycodone HCl 5 mg capsules
Chlordiazepoxide w/ Clidinium Bromide capsulesPentazocine & Acetaminophen tablets
Chlorzoxazone 250mgPentazocine & Naloxone tablets
Cilostazol tablets 100mgPhenazopyridine HCl 100 mg and 200 mg tablets
Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tabletsPhendimetrazine Tartrate 35mg tablets
Cyclobenzaprine HCL 5 mg and 10 mgPhentermine HCl 37.5 mg tablets
Dexchlorpheniramine Maleate 4 mg and 6 mg tabletsPhentermine HCl 15 mg, 30 mg and 37.5 mg capsules
Dipyridamole 25 mg, 50mg, and 75 mg tabletsPrenatal Formula 3 tablets
Glyburide 1.5 mg, 3.0 mg and 6.0 mg tabletsPrenatal Plus 27 mg FE tablets
Guaifenesin & Codeine Phosphate tabletsPrenatal Rx tablets
Guaifenesin & Phenylephrine tabletsQuinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets
Guanfacine 1.0 mg and 2.0 mg HCl tabletsRifampin 300mg capsules
Hydrocodone & Homatropine tabletsSodium FL 0.5 mg and 1.0 mg tablets
Hydromorphone HCl tabletsTizanidine HCl 2 mg and 4 mg tablets
Hydroxyzine 10 mg, 25 mg and 50 mg tabletsTrimethobenzamide 300mg capsules
Hyoscyamine Sulfate 0.125 mg SLTrimipramine Maleate 25mg, 50mg, 100mg capsules
Hyoscyamine Sulfate 0.375mg SR tabletsTrivita 1 mg FL tablets
Hyoscyamine Sulfate 0.125 mg (oral) tabletsUrsodiol capsules, 300mg
Isradipine 2.5 mg and 5 mg capsulesVitacon Forte capsules
Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsulesVitaplex Plus tablets
Meclizine Chewable 25 mg tabletsVitaplex tablets (FC)
Meloxicam 7.5 mg and 15 mg tabletsYohimbine HCl 5.4 mg tablets

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


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