Navigation Links
FDA Seizes All Drugs From Generics Maker
Date:6/25/2009

Agency cites poor quality at Michigan plants, warns of potential shortage of one pain reliever

THURSDAY, June 25 (HealthDay News) -- The seizure of all drugs and drug ingredients at a Michigan-based manufacturer by the U.S. Food and Drug Administration could lead to a shortage of a particular type of pain reliever, the agency said on Thursday.

The FDA ordered U.S. Marshals to seize the products from plants run by Caraco Pharmaceutical Laboratories Ltd in Detroit, Farmington Hills, and Wixom, Mich. Caraco manufactures generic drugs, including cardiac, psychiatric and pain medications, the FDA said in a Thursday afternoon press briefing.

"This action follows the company's continued failure to meet the FDA's current Good Manufacturing Practice requirements, which assure the quality of manufactured drugs," Deborah M. Autor, director of FDA's Office of Compliance, Center for Drug Evaluation and Research, said during an afternoon teleconference Thursday.

Caraco makes 33 drugs that may be affected, Autor said. She said that despite the action taken by the agency, consumers should still take any drugs made by Caraco that they may still have.

The seizure may cause a shortage of one pain drug, choline magnesium trisalicylate, in particular. However, the drug is used by only a small percentage of patients and patients can find alternatives by consulting their doctor, Autor said.

The FDA took the action due to Caraco's failure to meet the agency's Good Manufacturing Practice requirements after several warnings, Autor said. The FDA's action stops Caraco from distributing drugs until the company provides the agency assurance that it is complying with good manufacturing requirements.

Starting in January 2009, Caraco voluntarily recalled drugs that the FDA considered defective. The recalls were due to manufacturing defects, including oversized pills and possible errors in the contents of the drugs.

In May, the FDA inspected Caraco once again and found continued violations of good manufacturing practices.

"Caraco exhibited poor control of their raw materials used to make their products," David Jaworski, a consumer safety officer in FDA's Office of Compliance in the Center for Drug Evaluation and Research, said during the teleconference.

"Also we saw that the firm's tablet manufacturing processes had higher than normal variability, which we believe has not adequately been addressed. We have also observed poor decisions being made by the company's management who are responsible for the quality of the drug products being manufactured," he said.

The agency is looking to work with Caraco to correct the problems in its manufacturing process, Autor said.

"Our goal is to get Caraco up and running safely," Autor said. "Seizures often lead to major changes by companies that help them break a cycle of poor performance," she noted.

More information

For more information on recalled Caraco products, visit the U.S. Food and Drug Administration.



SOURCES: June 25, 2009, teleconference with: Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research; David Jaworski, consumer safety officer, Office of Compliance, Center for Drug Evaluation and Research, both U.S. Food and Drug Administration


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Is Your Teenager Using Prescription Drugs Behind Your Back? TestCountry Drug Test Panel Numbers Tally with NIDA Fact Sheet Reports on Prescription Drug A
2. Targeting tumor behavior may lead to new liver cancer drugs
3. Jiangbo Pharmaceuticals to Attend the 44th China New Drugs Trade Fair in Tianjin
4. CEL-SCI Scientist Invited to Discuss Plans to Launch Unique Manufacturing Process That Saves Cost While Enhancing the Shelf Life of Drugs at 5th Annual Aseptic Processing of Sterile Drug Products Conference
5. IUPUI chemists develop Distributed Drug Discovery: Finding drugs for neglected diseases
6. ADHD Drugs Linked to Sudden Death in Kids
7. Asthma Drugs Get Precaution Labeling for Possible Psychiatric Side Effects
8. New Home Drug Hair Test Kit Now Available from Bartell Drugs; HairConfirm Detects 90-Day Drug Use & Usage Frequency
9. Drugs against winter vomiting disease one step closer
10. Drugs Best First Defense Against Heart Disease for Diabetics
11. Two Drugs Better Than One for Crohns Patients
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Seizes All Drugs From Generics Maker
(Date:2/10/2016)... ... 10, 2016 , ... Everseat has joined the award-winning Allscripts ... physicians. The integration will enable Allscripts users to post open appointments to the ... app. , The partnership gives Everseat substantial added power to help Allscripts meet ...
(Date:2/10/2016)... ... February 10, 2016 , ... Workrite Ergonomics, who is celebrating their 25th ... humble beginnings to being an internationally recognized leader in their industry. , "We are ... Charlie Lawrence, President of Workrite. “Workrite recognized the importance of good ergonomics before ...
(Date:2/10/2016)... ... February 09, 2016 , ... Western University ... free oral screenings to 150 children in kindergarten through third grade at Hurley ... Dental Medicine joined Chinese American Dental Society of Southern California volunteers for Give ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... It’s that ... Traci Davis, the new president of the Interscholastic Athletic Association of Maryland (IAAM), Hall ... well how quickly fitness goals are cast aside. , That’s why one of her ...
(Date:2/9/2016)... ... , ... February is Heart Awareness Month, and to celebrate Health Quest Chiropractic ... the American Heart Association, New Mexico chapter. , A Heart Rate Variability (HRV) scan ... INSiGHT Pulse Wave Profiler utilizes a non-invasive technology to determine a heart’s ability to ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... 2016 On Tuesday, February 9th, the ... with its Arthritis Advisory Committee to discuss ... & Johnson,s Remicade and most likely the ... U.S. The Biologics Prescribers Collaborative (BPC) along ... for Patient Access, American Association of Clinical ...
(Date:2/10/2016)... aims to ensure 2,50,532 children between the ages ... th birthday   --> The campaign ... - 5 years reach the milestone of their 5 ... aims to ensure 2,50,532 children between the ages of 2 ... birthday   India , have launched the "Joy of Five" ...
(Date:2/9/2016)... -- Misonix, Inc. (NASDAQ: MSON ), an international ... innovative therapeutic ultrasonic products for spine surgery, skull-based ... and other surgical applications, today announced financial results ... of fiscal year 2016 ended December 31, 2015. ... Highlights for the second quarter and first ...
Breaking Medicine Technology: