PESTICIDE CONTAMINANT IN
TYLENOL RECALL pg2
KNOWN BACTERIA
Raw materials had known contamination of bacteria and were still used to manufacture several finished lots of children’s drug products. The bacteria could not be identified, but the finished products were tested free of contamination.
DUST AND DIRTY AREAS
Some pieces of equipment were covered with thick layers of Thedust and others were held together with duct tape.
SPECKS OF MACHINERY METAL
Numerous customer complaints about dark specks in the formula which were tiny bits of metal from some machinery.
TOO POTENT INGREDIENTS
Components of this medicine were not adequately tested.
Company changed the process of one of its infant Tylenol products and failed to check if procedures were working right
Some had 25% more active ingredient than prescribed but the FDA said chances of harm were remote. The company did not have laboratory facilities to test drug ingredients.
Complaints since September 2009about moldy smell in medicine and stomach upsets after taking it
Lack of public trust/FDA and Congress to continue investigation/round-the-clock inspectors will be at the facilities that must be paid for by the company
The lawmaker is well now scrutinize the performance of both the drugmaker and also federal regulators. This recall affects 70% of the market for over-the-counter pediatric liquid medicines. Questions arise whether FDA inspections and recall procedures are sufficient and whether the drug company has controls put in place.
The company failed to attract consumer complaints and spot trends that could signal a systematic problems. They lacked written procedures, and fail to adequately train employees.
Another company, Perrigo of Allegan Michigan, that makes the equivalent of these child medicines for pharmacy chains of CBS and Walgreens also received warning letter from the FDA about manufacturing violations including ibuprofen tablets contaminated with metal shavings.
J&J, which is based in New Brunswick, New Jersey, has long enjoyed a sterling corporate image, even ranking first place last year in a poll of company reputations.
A full list of the products can be found on the company’s Web site mcneilproductrecall.com.
That positive image The company's response to a cyanide tampering scare in Chicago that killed seven people in 1982 is considered a textbook example of how to deal with a brand crisis.
J&J had its sales force remove 264,000 Tylenol bottles from Chicago area storesis due in part to J&J's handling of past product recalls.
The company is the largest maker of store brand over-the-counter drugs. There are some similarities in the problems at both companies. Both companies, according to the FDA, have quality control issues
COMMENTARY
What will the FDA do about free-market quality control to detect these issues? The quality control issue is a big problem.
Are the processes and employee training in the manufacturing and quality and our organizational changes made in management along with quality control investigations.
These products have been trusted and there is a question by the public of quality control lapses that may be a pattern. Consumers will need to now find generic alternatives.
After being concerned about drugs manufactured in China and abroad elsewhere, it is shocking to find that we also lack quality controls.
The FDA has received hundreds of complaints, but fortunately no children have been harmed. The big harm is that the company has not lived up to its reputation. The big problem for the company is that when the government takes something Stock investors will also take it seriously.
Here again, this episode gives the FDA a boost to control drug makers. They may be able to expand their ability to order drug recalls, which now requires a lengthy legal process and court orders if the drugmaker refuses to voluntarily issue a recall. The J &J a company over 121 years old,also may be charged with civil or criminal charges.
The company has recently hired six new top officials to oversee quality and plant operations.
Are our federal regulators responding adequately?
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