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:5/29/2016)... ... May 29, 2016 , ... Whole Health Supply is happy ... KlipPro KP-240L clipper is available to the public. This is an unusual clipper because ... than the average clipper. , Everything about this product is concentrated on ease of ...
(Date:5/28/2016)... ... May 28, 2016 , ... "Color Grading media can be ... a preset onto their media," said Christina Austin - CEO of Pixel Film Studios. ... quickly and easily add stylish color grades to their footage. A LUT is a ...
(Date:5/28/2016)... ... ... the city where’s it’s easy to spot the neon lights of chains serving fast food, ... with a taste for real food. , On May 13, the Best Western ... casual restaurant focusing on dishes made by hand with wholesome, organic ingredients that are sourced ...
(Date:5/27/2016)... ... May 27, 2016 , ... Two director-level employees of Horizon Blue ... Women and Industry (TWIN) 2016 honorees. The award recognizes businesswomen who excel in ... Geri Boone, Director of the MLTSS (Managed Long-Term Services and Supports) Program at Horizon ...
(Date:5/27/2016)... ... 2016 , ... With over 60 percent of acute stroke survivors being left ... to aid in the rehabilitation process has steadily increased. Ekso Bionics had been working ... due to stroke. , Ekso Bionics has now received clearance from the U.S. Food ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... PUNE, India , May 27, 2016 ... in the instances of hypertension is driving ambulatory blood ... muscles lose their elasticity and their ability to respond ... blood pressure. This condition can lead to various cardiovascular ... and peripheral vascular disease. These diseases are growing in ...
(Date:5/26/2016)... , May 26, 2016 According ... "Medical Waste Management Market - U.S. Industry Analysis, Size, Share, ... management market in the U.S. was valued at US$ 5.89 ... CAGR of 3.4% from 2015 to 2023 to reach US$ ... analysis of current and emerging needle free drug delivery devices ...
(Date:5/25/2016)... May 25,2016 FDA 510(k) ... Cellvizio platform for urological and surgical applications ... inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy ... in the US with the 12 th ... Administration (FDA). This new FDA clearance covers Confocal ...
Breaking Medicine Technology: