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 capsules
Meperidine & Promethazine capsules
Amibid DM ER tablets
Meperidine HCl 100 mg and 50 mg tablets
Amibid DM tablets
Methenamine Mandelate 0.5 g and 1.0 g tablets
Amidrine capsules
Mirtazapine 15 mg, 30 mg, and 45 mg tablets
Amigesic 500 mg caplets and 750 mg caplets
Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg
Amitex PSE tablets
Multi-ret Folic 500 mg tablets
Bellamine S tablets
Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets
Betaxolol 10 mg and 20 mg tablets USP
Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets
Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets
Naltrexone 50mg tablets
Carisoprodol & Aspirin tablets
Oxycodone & Acetaminophen 5/500mg capsules
Carisoprodol, Aspirin & Codeine tablets
Oxycodone HCl 5 mg, 15 mg and 30 mg tablets
Carisoprodol 350mg tablets
Oxycodone HCl 5 mg capsules
Chlordiazepoxide w/ Clidinium Bromide capsules
Pentazocine & Acetaminophen tablets
Chlorzoxazone 250mg
Pentazocine & Naloxone tablets
Cilostazol tablets 100mg
Phenazopyridine HCl 100 mg and 200 mg tablets
Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets
Phendimetrazine Tartrate 35mg tablets
Cyclobenzaprine HCL 5 mg and 10 mg
Phentermine HCl 37.5 mg tablets
Dexchlorpheniramine Maleate 4 mg and 6 mg tablets
Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules
Dipyridamole 25 mg, 50mg, and 75 mg tablets
Prenatal Formula 3 tablets
Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets
Prenatal Plus 27 mg FE tablets
Guaifenesin & Codeine Phosphate tablets
Prenatal Rx tablets
Guaifenesin & Phenylephrine tablets
Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets
Guanfacine 1.0 mg and 2.0 mg HCl tablets
Rifampin 300mg capsules
Hydrocodone & Homatropine tablets
Sodium FL 0.5 mg and 1.0 mg tablets
Hydromorphone HCl tablets
Tizanidine HCl 2 mg and 4 mg tablets
Hydroxyzine 10 mg, 25 mg and 50 mg tablets
Trimethobenzamide 300mg capsules
Hyoscyamine Sulfate 0.125 mg SL
Trimipramine Maleate 25mg, 50mg, 100mg capsules
Hyoscyamine Sulfate 0.375mg SR tablets
Trivita 1 mg FL tablets
Hyoscyamine Sulfate 0.125 mg (oral) tablets
Ursodiol capsules, 300mg
Isradipine 2.5 mg and 5 mg capsules
Vitacon Forte capsules
Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules
Vitaplex Plus tablets
Meclizine Chewable 25 mg tablets
Vitaplex tablets (FC)
Meloxicam 7.5 mg and 15 mg tablets
Yohimbine HCl 5.4 mg tablets
Answers to frequently asked questions regarding this market action can be found on www.actavis.us/RecallFAQ.
