65 Activas drugs recalled

One of the world’s largest generic drug companies, Activas Totowa LLC, has launched a recall of 65 different drugs manufactured at a US plant after authorities said the facility was not meeting manufacturing standards.

Under the recall, which only affects drugs made at the company’s Little Falls, New Jersey facility, pharmacists and hospitals with supplies of the drug are being asked to return them to the manufacturer.

Because the recall has not been sparked by product complaints or health hazards, Activas said patients using any of the drugs should continue taking them in accordance with their prescription, as any sudden withdrawal in medication may place patients at risk.

Cayman Islands Medical Officer for Health Kiran Kumar said anyone with any of the listed medicines should consult with their physician or the pharmacy where the drug was purchased to discuss possible alternatives.

A US Food and Drug Administration inspection of the Little Falls, New Jersey facility earlier this year found that the plant did not meet the FDA’s or Activas’ standards for good manufacturing processes.

Below is a full list of products being recalled. Actavis products manufactured in other facilities are not affected by this recall.

• 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, Aspirin & Codeine tablets;
• Carisoprodol 350mg tablets;
• Chlordiazepoxide w/ Clidinium Bromide capsules;
• Chlorzoxazone 250mg
  Cilostazol tablets 100mg;
• Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets;
• 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 SL;
• Hyoscyamine Sulfate 0.375mg SR tablets;
• Hyoscyamine Sulfate 0.125 mg (oral) 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 0.5 mg and 1.0 mg FL & FE tablets;
• Multi–vita–bets 0.25 mg, 0.5 mg and 1 mg FL tablets;
• Naltrexone 50mg tablets;
• Oxycodone & Acetaminophen 5/500mg capsules;
• Oxycodone HCl 5 mg, 15 mg and 30 mg tablets;
• Oxycodone HCl 5 mg capsules;
• Pentazocine & Acetaminophen tablets;
• Pentazocine & Naloxone tablets;
• Phenazopyridine HCl 100 mg and 200 mg tablets;
• Phendimetrazine Tartrate 35mg tablets;
• Phentermine HCl 37.5 mg tablets;
• Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules;
• 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

Source : http://www.caycompass.com

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