Philadelphia Personal Injury Lawyers Blog

A federal investigation by the Food and Drug Administration at a plant in Lancaster, Pennsylvania operated by Johnson & Johnson found multiple violations that could harm the medications manufactured there.

The investigation found a pattern of inattention to detail. Equipment was found to be improperly cleaned and maintained. Problems at the plant were not investigated for significant periods of time and records were rarely maintained. Batches of medication manufactured during an equipment malfunction were not always quality checked. Popular over the counter medications such as Pepcid and Mylanta are manufactured at the plant.

This is the second plant shut down by J&J this year. A plant in Fort Washington, Pennsylvania was shut down after a massive recall was issued by J&J on many popular over the counter medications.

Related Sources:
New FDA report shows multiple lapses at J&J plant

More bad news for the over-the-counter medication manufactured by a Johnson & Johnson subsidiary, McNeil consumer products. A congressional investigation has revealed that in 2008, the company discovered problems with the Motrin formula but did not issue a recall. Instead the company hired an outside contractor to purchase the dangerous drugs.

In 2008, the company discovered a problem with their Motrin tablets. Johnson & Johnson was unsure if the tablet dissolved properly and appropriately administered the pain relieving ingredient, ibuprofen. In response, the company hired an outside contractor to buy samples of the medication and test the product to determine if a recall was an appropriate measure to take.

The outside company purchased lots of the medication and told employees specifically not to mention a recall and it never tested the medications for problems. In 2009, Johnson & Johnson recalled Motrin after the Food and Drug Administration confronted the company about the problems with the Motrin formula.

This revelation comes just a month after the massive recall of children's over the counter medication announced by Johnson & Johnson. Foreign particles were discovered in some batches of the medication and it is unknown if these particles could harm the children taking them. Since the recall the FDA has received hundreds of reports of injuries from the dangerous medications including seven deaths.

Related Sources:

Tylenol Manufacturing Plant Closed in Pennsylvania

FDA docs: J&J knew of problems with Motrin in 2008

A children's medication manufacturing plant in Fort Washington, Pennsylvania has been closed by McNeil Consumer products in the wake of the massive children's medication recall. The plant in suburban Philadelphia will not be allowed to resume manufacturing until deemed safe by the Food and Drug Administration.

An investigation by the FDA uncovered more than twenty manufacturing problems associated with the plant. The report noted that some machines were covered in dust and others were held together with duct tape. For the last year the FDA had been pressuring the plant to correct its problems and finally shut it down after the recall was issued. The report also mentions that McNeil's parent company, Johnson & Johnson failed to investigate over three dozen consumer complaints of quality issues associated with their products.

Health regulators at the manufacturing facility failed to test the raw ingredients for contaminants in the over the counter medication it was producing. An inspection from the FDA discovered there was no site in the plant to test the ingredients and bacteria was in fact found. It is unclear whether the bacteria reached the finished product in the recalled medications but health officials are still urging parents and care givers to refrain from giving the potentially dangerous medications to their children.

Related Sources:

Tylenol plant in Ft. Washington closed in wake of recall

FDA Found Bacteria In Lots For Recalled Tylenol

McNeil Product Recall Information

Parents and caregivers of children in Philadelphia may want to check their medicine cabinet for recently recalled medications. McNeil Consumer Healthcare has issued a recall of over 40 over-the-counter infant's and children's liquid medications because they do not meet quality standards.

Children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl are among the medications recalled by McNeil in cooperation with the Food and Drug Administration. Some of the medications recalled contain higher concentrations of the active ingredient than listed on the bottle. Other medications contain inactive ingredients and other particles that have not been subject to internal testing requirements.

Although no adverse effects of injuries have been reported, McNeil and the FDA are advising that consumers stop using the products immediately and discard of them appropriately.

For a complete list of the medications recalled please visit this website.

Related Sources:
Children's Liquid Cold, Allergy Medicines Recalled

McNeil Product Recall

The United States Consumer Product Safety Commission has recalled over a half a million units of Vicks DayQuil cold medicine because the packaging was found not to be child proof.

The 700,000 units were sold between September 2008 and December 2009 as Vicks DayQuil Cold & Flu 24-Count Bonus Pack Liquicaps. The packaging is marketed as child-resistant but the blister packs inside are not.

The UPC for this product is 3 23900 01087 1.

If a child was to open the medicine and ingest several of the pills they could suffer from serious health problems and death. Thankfully there have yet to be any reports of a child swallowing the medication.

This latest recall comes at not the most opportune time for Vicks and its parent company Proctor & Gamble. The company has already had 120,000 bottles of Vicks Sinex nasal spray recalled after bacteria were found in the spray. The Food & Drug Administration has also sent Vicks a letter warning them about the marketing of their products with Vitamin C.

Related Web Sources:

Red Orbit News

A Philadelphia mother recevied $2.5 million judgment against GlaxoSmith-Kline because a jury ruled that Paxil was responsible for her son's heart problems. The jury ruled 10-2 in favor of the mother citing that the drug manufacturer was negligent because they failed to warn doctors and patients of the risk to pregnant mothers.

The lawsuit is the first of hundreds to be filed in Philadelphia Court and many plaintiff lawyers are optimistic that their suits will have similar results. This particular case was difficult to prove in court because there are birth defects in 3 to 5 percent of all live births and it is hard to prove that a drug caused a birth defect in a child.

The jury's decision did not award the plaintiff compensatory damages because the jury did not find any evidence that GlaxoSmith-Kline knew about the potential side effects. Had documents surfaced that drug manufacturer knew of potential dangerous side effects but neglected to warn consumers or pull the drug off the market then compensatory damages would have been awarded.

GlaxoSmith-Kline is also battling law suits across the United States, Canada, and the United Kingdom for a different reason. There is evidence that Paxil users have a higher tendency to commit homicidal and suicidal acts. Already the drug manufacturer has settled cases outside of court and has had to deal with accusations of suppressing research that showed Paxil can lead to suicide.

If you believe you have been harmed by Paxil please do not hesitate to contact our experienced pharmaceutical litigation attorneys today to discuss your potential case.

Following years of litigation and FDA scrutiny, a subsidiary of Johnson & Johnson, Ortho-McNeil, has removed the reservoir Duragesic fentanyl patch from the market. Duragesic is one of J&J's top-selling drugs with more than $2 billion in sales in 2005 alone. However, the reservoir design can cause leaks which has led to numerous recalls. Fentanyl is 100 times more potent than morphine and therefore a leaking patch can be fatal. Our Fentanyl Patch Litigation Team has successfully prosecuted wrongful death cases throughout the entire United States representing the families whose loved ones have died as a result of leaking Duragesic reservoir patches. The FDA has investigated more than 120 deaths that may have been caused by the dangerous patch. After nineteen years of marketing and selling the reservoir design to the general public, J&J has replaced the reservoir patch design with a "new" design that they allege does not leak. However, Johnson & Johnson's "new design" is not new. Johnson & Johnson has been using the matrix technology in Europe for years. Additionally, generic manufacturers of the fentanyl patch have been using the matrix technology in the United States for years.

Continue reading "Johnson & Johnson Removes Reservoir Duragesic Patch From The Market" »

Brookstone Pharmaceuticals is recalling all lots of Concentrated Acetaminophen Drops in fear of patients overdosing on the drug.

An overdose of Acetaminophen can lead to liver toxicity, kidney damage and blood disorders. The FDA is investigating medication error reports that have lead to deaths and is considering that the concentrated acetaminophen should be removed from the market to lessen consumer confusion. The concentrated Acetaminophen drops contain 80 mg/0.8mL and regular strength Acetaminophen elixir contains 160mg/5mL.

The container that the concentrated drops come in is similar in size to regular strength preparations and the absence of an integrated dosage delivery system is leading to dosage errors and inadvertent overdosing. In efforts to mitigate confusion Brookstone has recalled all lots of its Concentrated Acetaminophen Drops and is requesting that any stores who have the product on its shelf to remove it immediately and return it to Brookstone for a full refund.

Continue reading "Concentrated Acetaminophen Drops Recalled" »

The Food and Drug Administration in correlation with the manufacturer and distributor of Hydroxycut dietary supplemt and weight loss products have issued a recall because of association with serious liver injuries. Injuries include hyperbilirubinemia, jaundice, liver damage, live transplant and death due to liver failure. The FDA has issued a letter to consumers to stop using the product immediately and have warned all Health Care Professionals of the potential liver injuries associated with the dietary supplement. None of the 23 reported cases had any risk factors or diseases associated with liver disease or injury. Some consumers regained liver function after the discontinuation of the supplement.

Hydroxycut® is distributed by Iovate Health Sciences, Inc. of Oakville, Ontario and Iovate Health Sciences USA, Inc. of Blasdell, New York. It is reported to be the number one selling over-the-counter dietary supplement for weight loss. The list of recalled products includes:

• Hydroxycut Regular Rapid Release Capsules


• Hydroxycut Caffeine-Free Rapid Release Caplets


• Hydroxycut Hardcore Liquid Caplets


• Hydroxycut Max Liquid Caplets


• Hydroxycut Regular Drink Packets


• Hydroxycut Caffeine-Free Drink Packets


• Hydroxycut Hardcore Drink Packets (Ignition Stix)


• Hydroxycut Max Drink Packets


• Hydroxycut Liquid Shots


• Hydroxycut Hardcore Ready-to-Drink (RTD)


• Hydroxycut Max Aqua Shed


• Hydroxycut 24


• Hydroxycut Carb Control


• Hydroxycut Natural

Continue reading "Dietary Supplement Hydroxycut Recalled Due to Liver Failure" »

A federal injunction has stopped Maryland based Neilgen Pharmaceuticals from selling more than 50 unapproved medications. Medications sold by Neilgen which also operates under the name, Unigen were mainly prescription cough and cold products. The U.S. Food and Drug Administration filed a complaint in Baltimore's U.S. District Court claiming the drugs were improperly manufactured, carried inadequate directions for use and were not FDA-approved.

Neilgen and its parent company, Advent Pharmaceuticals agreed to the injunction without admitting or denying the allegations. By agreeing to the injunction the company must destroy their existing drug supply and is prohibited them from manufacturing any new drugs without FDA approval. Outside counsel must also be hired to advise the company on complying with U.S. manufacturing standards. Any violation of the injunction will result in fines of over $1 million per year.

It is unclear on where the drugs were sold but an ongoing investigation by the Maryland U.S. attorney's office is hoping to discover where and when the drugs were sold.

The following cough and cold products were manufactured by the companies:

• RE All 12 Suspension


• BP Allergy Junior Suspension


• PE Tann 20 mg/CP Tann 4 mg Suspension


• BP New Allergy DM Suspension


• D-Tann CT Tablets


• B-Vex D Suspension


• Histex SR


• Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets

Continue reading "Unapproved Medication Pulled from Shelves" »

December 31, 2008 - Pricara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has recalled one lot of 50mcg/hr DURAGESIC® fentanyl patches with the lot number 0817239 and one lot of fentanyl patches sold by Sandoz Inc. with the lot number 0816851. Due to a manufacturing defect these lots may have a "cut" along one side of the patch. The result is a possible release of fentanyl gel from the patch, exposing patients or caregivers directly to the fentanyl gel causing serious injury or death. The Duragesic™ Patch litigation in which Eisenberg, Rothweiler, Winkler, Eisenberg & Jeck PC has taken a leading role, involves recalled patches and other Duragesic patches that are suspected of leaking fentanyl leading to the death of our clients due to "fentanyl toxicity."

Continue reading "Fentanyl Patch Update" »

The Food & Drug Administration has issued a Class 1 recall of 471,000 Covidien ReliOn insulin syringes sold at Wal-Mart & Sam Club's between July and October 2008. The hypodermic syringes have been mislabeled and as a result a patient could receive over double the dose of prescribed insulin. Class 1 recalls are reserved for situations in which continued use of the product could cause serious injury or death.

The syringes affected by the recall are sold under the brand name of ReliOn and are of the 1cc, 31-gauge variety. They are sold in packages of 100 units for use with U-100 insulin. Syringes labeled for use with U-40 unit insulin were placed in packages with syringes labeled for use with U-100 insulin. If a patient was to use a mislabeled syringe they could receive as much as 2.5 times the prescribed dose. The overdose of insulin could lead to hypoglycemia, abnormally low level of blood sugar, which could lead to serious health consequences or death.

Continue reading "Over 450,000 Insulin Syringes Recalled Due to Deadly Labeling Error" »

Actavis Totowa, a major generic drug manufacturer, is voluntarily recalling all products manufactured at its Little Falls, New Jersey plant. The recall comes after a FDA inspection that found the manufacturing standards were not up to FDA or Actavis standards.

The following are the prescribed medications affected by the recall:

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 45 mg
Amitex PSE tablets
Multi-ret Folic 500 mg tablets
Bellamine S tablets
Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets
Betaxolol 10 mg and 20 mg tablets USP
Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets
Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets
Naltrexone 50mg tablets
Carisoprodol & Aspirin tablets
Oxycodone & Acetaminophen 5/500mg capsules
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 mg and 1000 mg tablets
Phendimetrazine Tartrate 35mg tablets
Cyclobenzaprine HCL 5 mg and 10 mg
Phentermine HCl 37.5 mg tablets
Dexchlorpheniramine Maleate 4 mg and 6 mg tablets
Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules
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 20 mg/25 mg tablets
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

If you have been prescribed any of the drugs mentioned in the recall, do not stop taking your medication as prescribed, but do talk to your doctor or pharmacy about replacement medications.

If you or someone you know has been harmed by any of the above drugs, please contact us today to speak with an experienced attorney who will enable you or a loved one to seek compensation.