The lawyers and attorneys at our firm are currently offering free case evaluations to individuals injured by defective generic drugs manufactured by Actavis Totowa LLC at its Falls River, New Jersey facility. On August 1, 2008, Actavis Totowa recalled all generic drugs made at that facility because of manufacturing issues. If you believe you suffered an adverse reaction from one of these recalled medications, we urge you to contact one of our Actavis Totowa generic drug recall lawyers as soon as possible to protect your rights.
The Actavis Totowa generic drug recall lawyers at our firm have learned that the company’s Falls River manufacturing plant has been the subject of numerous safety issues in the past. This includes one other drug recall, as well as a warning letter issued by the Food & Drug Administration (FDA) in 2007 regarding inadequate conditions at the plant. Clearly, the fact that Actavis Totowa has found it necessary to recall every medication made at Falls River indicates that previous safety problems were not adequately addressed. Our Actavis Totowa generic drug recall lawyers intend to hold this company responsible for this failure.
Actavis Totowa Generic Drug Recall
The Actavis Totowa generic drug recall was initiated after an inspection of the facility revealed that operations did not meet the FDA’s standards for good manufacturing practices. Actavis Totowa asked pharmacies, hospitals and retailers to return the affected prescription medications.
The Actavis Totowa generic drug recall was initiated at the retail level only, and patients were not told to discard of their potentially defective medications. Both the company and the FDA have maintained that the recall is precautionary, and that no injuries have been reported as a result of the defective generic drugs.However, the vast majority of adverse drug reactions are never reported, and our Actavis Totowa generic drug recall lawyers believe that it is entirely possible that these shoddy medications have already injured many people.
The Actavis Totowa generic drug recall involved dozens of medications. The drugs recalled were:
- 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
If you or someone you know have taken any of these recalled medications and suffered a side effect or injury, we urge you to contact one of our Actavis Totowa generic drug recall lawyers right away.
Previous Actavis Totowa Safety Problems
Actavis Totowa has had a history of safety problems. Months before its generic drug recall, in April 2008, Actavis recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal digitalis reactions in users. Some of the faulty Digitek tablets involved in this earlier recall were made at the New Jersey facility.
The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports. But because not all adverse reactions are reported to the FDA or manufacturers, the true number could be much higher.
In February 2007, the FDA issued a warning letter to Actavis Totowa following an inspection of the Little Falls facility completed in August 2006. The violations cited in that letter included: significant deficiencies in the company’s quality control unit; laboratory notebooks that did not include all raw test data generated during testing; failure to check for accuracy the inputs to and outputs from the “Total Chrom Data Acquisition System,” which was used to run the firm’s HPLC instruments; quality control failed to recognize that some tablets that did not meet in-process specifications; lack of adequate procedures for conducting bulk product holding time studies; cleaning validation studies were found to be inadequate; master and batch production and control records were found to be deficient; and equipment used in the manufacture of Benztropine Mesylate tablets and other drug products was not adequately qualified.
In the warning letter, the FDA stated that it had reviewed the firm’s corrective actions promised in a letter dated Aug. 29, 2006. The agency found that while corrections the firm promised in its correspondence appeared to adequately address many of the violations, the FDA reiterated its concern about the quality of drug products that were released from the facility under the serious lack of controls found during the inspection.
Need Legal Help Regarding Actavis?
The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
