Navigation Links
FDA Found Bacteria in Ingredients for Recalled Tylenol, Benadryl

Agency also cited maker Johnson & Johnson for 'numerous deficiencies' at plant

TUESDAY, May 4 (HealthDay News) -- Bacterial contamination has been found in ingredients used to make the liquid cold and allergy products for children that were recalled Friday by drug giant McNeil Consumer Healthcare, according to a report issued late Tuesday by the U.S. Food and Drug Administration.

Last Friday, McNeil initiated a voluntary recall of more than 40 products, including liquid Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. These medications have been sold in the United States and 11 other countries. In all, about 1,500 lots of these products have been recalled.

The company also closed its plant in Fort Washington, Pa., where the contaminated products were made. The plant remains closed and cannot reopen without FDA approval.

Speaking at a Tuesday afternoon press briefing, Deborah M. Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research, said that in February, the agency met with executives of McNeil Healthcare and its corporate parent Johnson & Johnson to complain about the company's manufacturing practices.

McNeil had received 46 consumer complaints of foreign substances in its products, the FDA said.

In mid-April, the FDA began its inspection of the plant and found "numerous deficiencies in the way products were manufactured and the way the manufacturing process for those products was controlled," Autor said. The inspection process finished Friday.

These deficiencies included poor manufacturing practices and failure to maintain proper facilities and procedures for testing drugs, Autor said.

According to the agency report, some of the raw materials used to make products such as liquid Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl were found to be contaminated with as yet-unknown bacteria.

In turn, these raw materials were used to make finished products, Autor said. "The problems that we have actually seen in products that are on the market are ones that we do not believe will cause a significant medical concern," she said. "Based on what we have seen, we don't have concrete information to believe there is a serious medical concern."

Exactly what the bacteria is is not yet known, said Michael A. Chappell, acting associate commissioner for regulatory affairs. "I don't have that information," he said during the press briefing.

None of the finished products tested by the agency were positive for bacteria, he added.

Parents should discontinue use of the recalled products, and alternative products are available, FDA commissioner Dr. Margaret A. Hamburg said during news conference. She said that parents should not be unduly alarmed, since "the potential for serious health problems is remote."

According to Autor, the FDA is now evaluating the report and will decide if any regulatory action is needed. "The findings are serious, but we cannot say whether further action by FDA is warranted," she said.

More information

For more information on the recall, head to a special "What Consumers Need to Know" page at the U.S. Food and Drug Administration.

SOURCES: May 4, 2010, press teleconference with: Margaret A. Hamburg, M.D., Commissioner; Michael A. Chappell, Acting Associate Commissioner for Regulatory Affairs; Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research all U.S. Food and Drug Administration

Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Fear of Proactive Chat Unfounded According to Research by Bold Software
2. Lupus Awareness Month Kicks Off at Rockefeller Center: EHE International Donates Display Window to S.L.E. Lupus Foundation for May
3. Indeterminate breast lesions found in high-risk patients should be evaluated aggressively to exclude malignancy
4. Jeffrey Gottfurcht Children's Arthritis Foundation Launches With Mount Everest Climb
5. ASGE and ASGE Foundation hold Crystal Awards dinner at Digestive Disease Week
6. Endometriosis Foundation of America to Present Landmark Scientific Symposium in NYC
7. Largest Internet Supplier of Eternity Rings Pledges 10% of their Profits to the National Breast Cancer Foundation
8. Outstanding young gastroenterologists receive AGA Foundation 2010 Research Scholars Award
9. Outstanding young gastroenterologists receive AGA Foundation
10. Second AGA Foundation/Bernard Lee Schwartz Foundation Research Scholar Award presented
11. Johns Hopkins School of Medicine enters collaboration with New York Stem Cell Foundation
Post Your Comments:
(Date:6/27/2016)... ... 27, 2016 , ... The OSHA Training Center at ... Center headquartered in Northern California, has issued an important reminder to employers to ... Employers with workers exposed to high temperatures should establish a complete heat ...
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... announced today its affiliation with Tennessee Counseling Association. This new relationship ... of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... announced its strategic partnership with Connance, a healthcare industry leader providing predictive ... proven, proprietary technology combine to provide health systems, hospitals and ambulatory surgical ...
(Date:6/27/2016)... ... 2016 , ... A revolution is underway. Brooklyn-based company, ... for the millions of people who require these medical transport services annually. ... the use of technology. Now, SmartEMS has put forth an industry-changing app that ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Consumers have ... and regulators/payers have placed more emphasis on patient ... patient support programs in the pharmaceutical industry have ... medications. Consequently, pharmaceutical companies are focusing on becoming ... are providing products and services that improve health. ...
(Date:6/24/2016)... -- Dublin ... the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global market ... its applications in various applications. The report deals with ... main industries: pharmaceutical and biotechnology, food and beverage, and ...
(Date:6/24/2016)... Mass. and SAN CLEMENTE, Calif. , ... California -based mobile pulmonary function testing company, is now able ... PFT devices developed by ndd Medical Technologies , Inc. ... testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® ... , can get any needed testing done in the comfort ...
Breaking Medicine Technology: