Navigation Links
Major Manufacturer of Unapproved and Adulterated Drugs

ROCKVILLE, Md., April 25, 2007-The U.S. Food and Drug Administration (FDA) announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab's president, and Russ McMahen, PFab's vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.

“Drug approval and CGMP compliance are part of the foundation of drug safety,” said Steven K. Galson, M.D., M.P.H, director of FDA’s Center for Drug Evaluation and Research (CDER). “When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively.”

PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.

The unapproved drugs manufactured by PharmaFab include, but are not limited to:

  • De-Congestine Sustained Release Capsules;
  • GFN 1200/DM 60/PSE 60 Extended-Release Tablets;
  • Rhinacon A Tablets;
  • Sudal 12 Chewable Tablets;
  • Histex PD 12 Suspension;
  • Atuss HX CIII;
  • Ergotrate Tablets; and Hyoscyamine Sulfate Time-Release Capsules.

Because these drugs have not undergone FDA approval, their safety and effectiveness have not
been established, and FDA has not reviewed the adequacy and accuracy of the directions and
'"/>




Page: 1 2 3

Related medicine technology :

1. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
2. Major New Review Supports the Broader Potential of CeNeS COMT Inhibitor Discovery Programme
3. New Study Results Provide Additional Data about Short- and Long-Term Use of Desvenlafaxine Succinate in the Treatment of Adults with Major Depressive Disorder
4. Pooled Studies Showed Desvenlafaxine Succinate Significantly Improved Painful Symptoms and Anxious Symptoms Associated with Major Depressive Disorder in Adults, Compared With Placebo
5. Six-Week Investigational Study In Adults With Major Depressive Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole Therapy With Antidepressants
6. Exforge Helps Vast Majority of Patients Effectively Control Their Blood Pressure After Failing on Other Medicines, According to New Clinical Data
7. CuraGen and TopoTarget Announce New Clinical Results With Belinostat to be Reported at Upcoming Major Medical Meetings
8. Introgen Presents ADVEXIN Biomarker Data at Major Cancer Conference
9. Schering-Plough Addresses Major Milestones and Challenges in Treatment of Patients With Chronic Hepatitis C
10. New Clinical Data for Cytogens Quadramet and Prostacint to be Reported at Upcoming Major Medical Meetings
11. Major Discovery Raises Prospect of Better Patient Care By Improving Platelet Life Span
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Major Manufacturer Unapproved and Adulterated Drugs
(Date:8/29/2014)... DUBLIN , Aug. 29, 2014 Research ... CNS Disorders Drug Pipeline Insight 2014" report to their ... market in US is one of the largest segments of ... an alarming rate, while the available therapies were unable to ... growth in the market for CNS disorder, especially over the ...
(Date:8/29/2014)... , Aug. 29, 2014  United Therapeutics Corporation (NASDAQ: ... District Court for the District of New ... the company,s case against Sandoz, Inc. regarding United Therapeutics, ... Sheridan ruled that U.S. Patent No. 6,765,117 is ... Sandoz from marketing its generic product until the expiration ...
(Date:8/29/2014)... Pa. , Aug. 29, 2014  Unilife Corporation ... UNS) announced today that it intends to release its ... year ended June 30, 2014 after market trading ends ... has scheduled a conference call for 4:30 p.m. U.S. ... 2014 at 6:30 a.m. AEST), to review the Company,s financial ...
Breaking Medicine Technology:US CNS Disorders Drug Pipeline Insight 2014 2District Court Decision Received In Remodulin Patent Case 2Unilife Corporation to Announce Financial Results for Fiscal Year 2014 Fourth Quarter and Year End on Tuesday, September 9, 2014 2
... 2011 ChromaDex® Corp. (OTCBB: CDXC) today announced ... ChromaDex® the exclusive rights to a joint patent ... the method of inducing UDP-glucuronosyltransferase (UGT) activity using ... found in blueberries and demonstrated to have multiple ...
... (Nasdaq: NKTR ) today announced that dosing ... multiple ascending doses of NKTR-181, the company,s novel opioid ... once- or twice-daily oral tablet for the treatment of ... liability and serious central nervous system (CNS) side effects ...
Cached Medicine Technology:ChromaDex®'s Novel Ingredient pTeroPure® to be Studied as Potential Treatment for Fighting Skin Cancers 2ChromaDex®'s Novel Ingredient pTeroPure® to be Studied as Potential Treatment for Fighting Skin Cancers 3Nektar Initiates Second Phase 1 Clinical Study Evaluating NKTR-181, A Novel Opioid Molecule, for Treatment of Chronic Pain 2Nektar Initiates Second Phase 1 Clinical Study Evaluating NKTR-181, A Novel Opioid Molecule, for Treatment of Chronic Pain 3Nektar Initiates Second Phase 1 Clinical Study Evaluating NKTR-181, A Novel Opioid Molecule, for Treatment of Chronic Pain 4Nektar Initiates Second Phase 1 Clinical Study Evaluating NKTR-181, A Novel Opioid Molecule, for Treatment of Chronic Pain 5Nektar Initiates Second Phase 1 Clinical Study Evaluating NKTR-181, A Novel Opioid Molecule, for Treatment of Chronic Pain 6
(Date:8/30/2014)... a plant-based medication commonly used to treat gout, ... in reducing potential complications from this type of ... gastrointestinal adverse effects, according to a study published ... released early online to coincide with its presentation ... Common complications after cardiac surgery include postpericardiotomy syndrome ...
(Date:8/30/2014)... "My niece developed a nighttime fever, ... moment, her fever might get worse," said an inventor ... aware of how she was doing, I developed this ... continuously monitor a child's temperature. The unit instantly alerts ... that prompt medical care can be given, which is ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 Bringing forth ... By Search announces the Labor Day discount on ... will surely get the complete services related to internet ... professionals, Content Writers, and others do have a deep ... that reflects in their work and since the inception, ...
(Date:8/30/2014)... PA (PRWEB) August 30, 2014 "I had ... because of her crutches," said an inventor from Wetumpka, Ala. ... sights and sounds of the shore, I came up with ... sand." , She created a prototype for the patent-pending Deezers ... accessory enables the individual to use crutches, walkers, or canes ...
(Date:8/30/2014)... Bethesda, MD (PRWEB) August 30, 2014 In ... and increasingly difficult to get. Snoring and sleep apnea (a ... stops) robs people and their bed partners of the rest ... to 45% of the population snores and 20 million people ... only 10% have been diagnosed and treated; and of those ...
Breaking Medicine News(10 mins):Health News:Medication shows mixed results in reducing complications from cardiac surgery 2Health News:Profit By Search Announces Labor Day Discount on SEO Services 2Health News:Snoring: Bad for Relationships, Bad for Health 2Health News:Snoring: Bad for Relationships, Bad for Health 3
... ... WAYNE, Pa., Nov. 13 Escalon Medical Corp.,(Nasdaq: ESMC ... 2008., For the first quarter of fiscal 2009, the Company ... This,included product revenue of $8,669,000 for the first quarter of fiscal,2009, ...
... Nov. 13 The fourth annual EagleBank,Foundation Fight ... local hospitals were the primary beneficiaries: Shady Grove,Adventist ... and The,George Washington University Hospital, Providence Hospital and ... the Primary Care,Coalition of Montgomery County. The tournament ...
... FORT LAUDERDALE, Fla., Nov. 13 eDiets.com,Inc. (Nasdaq: ... fitness,and healthy lifestyle solutions, today announced results for the ... Revenues for the third quarter of 2008 were $4.8 ... Net loss for the quarter was $(3.2),million, or $(0.13) ...
... urging safe sex practices, study says , , THURSDAY, ... for pelvic inflammatory disease (PID) become highly vulnerable ... or months after treatment, researchers at Johns Hopkins ... the researchers, suggest that treating PID "with a ...
... Nov. 13 Watson,Pharmaceuticals, Inc. (NYSE: ... announced that its New Drug Application (NDA) ... a luteinizing hormone,releasing hormone (LHRH) agonist, has ... and Drug Administration (FDA). Watson is seeking ...
... 13 In a regular session of,the New York ... the cover of,a contentious election year and an economic ... Appeals (NYCOA) declined to hear the appeal of,Kathryn Jordan ... by a woman with Multiple Sclerosis. The appeal was,filed ...
Cached Medicine News:Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 2Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 3Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 4Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 5Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 6Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 7Health News:Escalon(R) Reports First Quarter Fiscal 2009 Results 8Health News:Fourth Annual EagleBank Foundation Fight Breast Cancer Golf Classic Raises Over $100,000 2Health News:eDiets.com(R) Announces Q3 2008 Results 2Health News:eDiets.com(R) Announces Q3 2008 Results 3Health News:eDiets.com(R) Announces Q3 2008 Results 4Health News:eDiets.com(R) Announces Q3 2008 Results 5Health News:eDiets.com(R) Announces Q3 2008 Results 6Health News:eDiets.com(R) Announces Q3 2008 Results 7Health News:Pelvic Inflammation Puts Girls at Risk for Repeat STIs 2Health News:Watson Announces the NDA for a 6-Month Formulation of TRELSTAR(R) Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer 2Health News:Watson Announces the NDA for a 6-Month Formulation of TRELSTAR(R) Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer 3Health News:Watson Announces the NDA for a 6-Month Formulation of TRELSTAR(R) Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer 4Health News:Top NY Court Blinks in 'First Department' WPP Discrimination Power Play 2Health News:Top NY Court Blinks in 'First Department' WPP Discrimination Power Play 3Health News:Top NY Court Blinks in 'First Department' WPP Discrimination Power Play 4Health News:Top NY Court Blinks in 'First Department' WPP Discrimination Power Play 5