Actavis Totowa, makers of the recalled Digitek brand of digoxin, have announced a voluntary recall on all pharmaceutical drug products produced at their Little Falls, NJ drug manufacturing facility.
Although Actavis Totowa states that this recall is “not prompted by product complaints or health hazards associated with the products”, it comes after a major recall of Digitek/digoxin tablets that were reportedly produced at twice the dosage listed on packaging, possibly at higher doses than deemed safe for use in humans. However, ceasing the use of a drug suddenly may have its own dangers, so consumers are advised to discuss the situation with their doctor before discontinuing the use of drugs produced by Actavis Totowa.
An FDA inspection in 2006, and another one earlier this year found that plant operations did not meet the FDA’s standards for good manufacturing practices. Actavis Totowa has stated in a press release on August 1st that the voluntary recall was in response to the 2008 FDA inspection results.
This recall includes the following products made by the Actavis Totowa in New Jersey (Note – Digitek has already been recalled and has spawned several wrongful death lawsuits):
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 |
Amitex PSE tablets |
Multi-ret Folic 500 mg tablets |
Bellamine S tablets |
Multi-vita-bets 0.5 mg and 1.0 mg FL & FE |
Betaxolol 10 mg and 20 mg tablets USP |
Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg |
Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg |
Naltrexone 50mg tablets |
Carisoprodol & Aspirin tablets |
Oxycodone & Acetaminophen 5/500mg |
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 |
Phendimetrazine Tartrate 35mg tablets |
Cyclobenzaprine HCL 5 mg and 10 mg |
Phentermine HCl 37.5 mg tablets |
Dexchlorpheniramine Maleate 4 mg and 6 mg |
Phentermine HCl 15 mg, 30 mg and 37.5 mg |
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 |
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 |
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