It was a difficult year in 2010 for giant drug provider Johnson & Johnson. After facing several class action law suits over recalled children’s medications, the problems continue this week as an announcement has been made public of a recall of commonly used OTC drugs, after a problem with quality control in their McNeil manufacturing plant in Pennsylvania.

Tylenol, which controls 35% of the pain killer market, Benadryl, Sudafed and Sinutab have been recalled on the wholesale level after production records demonstrated poor cleaning procedures, a lack of proper documentation of maintenance procedures before the plant was completely shut down in April of 2010. That closing lead to a huge recall of over 40 types of medications including Benadryl and Motrin.

In July 2010 five children’s medication lawsuits were filed by six different consumers in the U.S. District Court for the District of Northern Illinois. The lawsuits accused Johnson & Johnson of fraud and racketeering, saying that the company failed to recall the drugs properly and did not do enough to allow consumers to recover losses. A Food and Drug Administration report said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled.

This most recent recall affects Tylenol allergy, cold and sinus cool burst caplets, Tylenol arthritis pain geltabs, Tylenol 8-hour caplets, Benadryl allergy kapgels and caplets, Sudafed PE caplets, and Sinutab Sinus caplets. It is not likely however that the quality of the drugs is impacted. The drugs were all made at the plant prior to the shutdown.

In addition, last week the state of Oregon’s attorney general filed a lawsuit against Johnson & Johnson claiming that the company had conducted a ‘phantom’ Motrin recall in 2008 by hiring contractors to buy out the supply of drugs from every store, instead of announcing that there had been defective batches of the drug released to the public.

On September 29, 1982, a “Tylenol scare” began when the first of seven individuals died in metropolitan Chicago, after ingesting Extra Strength Tylenol that had been deliberately contaminated with cyanide. Within a week, the company pulled 31 million bottles of tablets back from retailers, making it one of the first major recalls in American history.

The crime was never solved and Tylenol sales temporarily collapsed, but the brand was rebuilt and recovered in a few years. At the request of later Chairman, Joseph Chiesa, new product consultant Calle & Company rescued the brand with the invention of the first inherently tamper-proof capsule, Tylenol Gelcaps, recapturing the 92% of capsule segment sales lost after the cyanide incident. The scare led to the introduction of tamper-evident packaging and “gelcaps” across the prescription drug industry.

Source: McNeil

Written By Sy Kraft, B.A.