Pharmaceutical manufacturer Actavis Totowa announced a voluntary recall of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility. The recall follows an inspection conducted by the Food & Drug Administration earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.

Actavis acknowledges that the Little Falls facility does not meet the company’s own standards for good manufacturing practices. As a result, Actavis made the decision to recall products manufactured at that facility at the pharmacy/retail level, including wholesalers and hospitals. Actavis has notified the FDA of this action.

Earlier this year, in April 2008, Actavis Totowa issued a Class I recall of its Digitek product, which is used to treat heart problems, after it was discovered that tablets may have been manufactured at twice their intended thickness, doubling the amount of medication in the pills and putting patients at risk for serious complications as a result of higher dosages than intended.

The company says there have NOT been any product complaints or negative health incidents reported involving products affected by this new recall, but it is recalling the drugs as a precaution. All of the recalled products are prescription medications.

The manufacturer recommends that patients currently taking the affected medications should NOT stop taking the drugs, as a sudden stop in medication could be dangerous, but patients should consult with their physician or pharmacist for replacement medication.

Actavis Totowa has issued recall letters to wholesalers and retailers. Following is a list of recalled drugs:

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

For more information, visit Actavis Totowa online.



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