Bioelectronics Corp (BIEL)

[Simpsonly]

I was wondering if the FDA was assisted in doing its proper job by FDA oversight, competitors of BIEL or by others. Folks could laugh at me and say, "Are you kidding, BIEL will never be a competitor of Johnson &Johnson, manufacturers of the Tylenol line of products. J&J clearly have their own issues from the old news I found from a year ago or so.
I have used ActiPatch on a badly sprained tennis ankle and have no need for any other product for sprains, strains PlanterFac ligament issues etc. That makes BIEL a winning competitor over J&J and when the FDA approves other BIEL products in addition to the post-surgery eye device already FDA approved this company will be on very solid ground.
J&J's contamination of product from a chemical reaction from the pallets used to store product resulted in a recall? Product testing found the problem and protected consumers, all good. If I am J&J and I see BIEL is not following FDA protocols? It's normal for someone to make the call. Now that BIEL is apparently in compliance, it is old news, I think. Great work by the poster who found the warning letter within a few days. I found the link below in the public domaine by searching - Tylenol manufacturer, so it is proof the rules are the to protect us all and sometimes they work. But can you imagine not having to take pills for a wide range of aches and pains? They only mask the pain, while I believe ActiPatch got to the core healing issue of the sprain, and helped the damaged tissue recover faster than normal recovery times. First-hand ActiPatch worked amazingly well by obliterating the pain while I was healing in days instead of weeks on crutches.


http://www.lakecharleslapersonalinjury.com/2011/03/additional-products-liability-issues-for-tylenol-manufacturer.shtml
On behalf of Veron, Bice, Palermo & Wilson, LLC posted in Product Liability

HEADLINE
Additional products liability issues for Tylenol manufacturer

31 March 2011
A couple of weeks ago we talked about how the company Johnson & Johnson faced product liability issues over the recall and production of Tylenol. The company failed to follow federal manufacturing guidelines in three of its factories that produce Tylenol and as a result the government took over the facilities to avoid further product safety issues. But, it appears the product liability issues for Johnson & Johnson and Tylenol are not over.

The company has recalled another lot of Tylenol voluntarily because of consumer complaints about a strange, musty odor. The company has recalled one lot of Tylenol 8 Hour Extended Release Caplets. One lot is around 34,000, 150 count bottles. Johnson & Johnson believes the strange odor was caused by small amounts of chemicals called 2, 4, 6-trichloroanisole (TCA) and 2, 4, 6-tribromoanisole (TBA). The decomposition of a chemical in wood pallets used to transport and store the packaging materials for the company's products creates TBA.

Consumers who have used the contaminated pain-relievers have experienced stomach issues though the medical issues are not serious according to one doctor reporting on the incident. The doctor said, "They're not that severe -- we're talking about vomiting, diarrhea."

The affected medicine was produced at the McNeil Consumer Healthcare plant in Fort Washington, PA before the production site was voluntarily closed in April 2010. The company recalled 128,000 bottles of the same product in October 2010, and in July 2010 the company recalled 21 different products including Motrin, Benadryl and Children's Tylenol. In April 2010, the company conducted the largest recall of children's medicine recalling 130 million bottles involving over 40 products.

Source: ABC News, "Johnson & Johnson recalls yet more Tylenol," Katie Moisse and Kim Carollo, 3/30/11