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Actavis Recall

Actavis Recall Side Effects May Lead To Lawsuits

Actavis Recall | Lawyers, Lawsuits | Side Effects: Failed FDA Inspection, Adverse Reactions, Inadequate Plant Conditions

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.

Legal Help for Victims of Defective Actavis Totowa Generic Drugs

If you or a loved believe you were injured by a defective generic drug recently recalled by Actavis Totowa, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with an experienced Actavis Totowa generic drug recall lawyer.


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Actavis Reopens Plant Closed After Digitek, Other Drug Recalls

Apr 20, 2009 | Parker Waichman LLP
Actavis Totowa has received approval from the Food & Drug Administration (FDA) to reintroduce Oxycodone tablets made at its Little Falls, NJ facility.  The Little Falls plant was one of three closed last year following recalls of oversized Digitek (Digoxin) tablets and other defective generic drugs.Actavis agreed to temporarily close its Little Falls manufacturing facility, as well as another in Riverview and a packaging plant in Taft as part of a Consent Decree it reached with federal...

Following Digitek, Other Drug Recalls, Feds Seek to Shutter Actavis Facilities

Nov 18, 2008 | Parker Waichman LLP
Actavis Totowa, LLC, the maker of defective Digitek tablets, now faces a lawsuit filed by the U.S. Justice Department that seeks to shut down substandard manufacturing plants in New Jersey.   In April 2008, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek.  According to the Food & Drug Administration (FDA), the Digitek defect could cause serious and even fatal reactions in users. The FDA...

Digitek, Other Generic Drug Recalls Prompt Congressional Probe of Actavis Totowa

Oct 10, 2008 | Parker Waichman LLP
Actavis Totowa, the company that has recalled a variety of drugs this year, including Digitek tablets and fentanyl patches, has attracted the attention of lawmakers on the House Energy and Commerce Committee.  Chairman John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich.) have sent a letter to the Food & Drug Administration (FDA) seeking information about the Actavis recalls. In April 2008, Actavis Totowa recalled Digitek tablets because...

Suit Over Phenytoin Names 10 Defendants in Woman’s Death

Aug 15, 2008 | Parker Waichman LLP
According to court papers, Agnes Davis was prescribed phenytoin and then suffered a severe adverse reaction- Stevens-Johnson Syndrome - that allegedly led to her death.  Phenytoin is a generic version of Dilantin.  The lawsuit, filed by Willie Davis Jr. and Alice Washington—Davis’s family members—on August. 8, 2008, names 10 companies that make, label, test, market, or distribute phenytoin.  Among other issues, the defendents allege that the defendants misled...

CEO Leaves Actavis Group

Aug 6, 2008 | Parker Waichman LLP
Just days after its U.S. division recalled all of its generic drugs, Icelandic drug maker Actavis Group announced that its CEO is stepping down.  However, in announcing the departure of Róbert Wessman, the company made no mention of Actavis Totowa's recent safety problems, which also included an April recall of Digitek tablets.Instead, media reports say Wessman  was stepping down to focus on his investment company Salt Investment, but will continue to have a seat on the board...

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