Navigation Links
FDA Found Bacteria in Ingredients for Recalled Tylenol, Benadryl
Date:5/4/2010

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:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... , ... October 13, 2017 , ... As health professionals ... known as “patient engagement.” The patient is doing more than filling out a survey; ... , “There is an increasing emphasis in health care and research on the importance ...
(Date:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 2017  True Health, a leader in integrated ... during National Breast Cancer Awareness month to educate ... Research recently published ... more than 10 million American women are at ... or BRCA2 and have not had testing. These mutations ...
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/4/2017)... LAWRENCE, Mass. , Oct. 4, 2017 /PRNewswire/ ... developer of single-use, self-contained, illuminating medical devices, today ... National Health Surveillance Agency (or Agência Nacional ... ®. The first single-use, cordless surgical retractor with ... ONETRAC provides optimal access, illumination and exposure of ...
Breaking Medicine Technology: