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What’s In An FDA Warning? J & J and Recalls,Insulin Pumps, Etc.

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The growing problem of quality problems at Johnson & Johnson has prompted federal regulators at the U.S. Food and Drug Administration (FDA) to warn the company, The same organization that produces baby powder, shampoo and lotions parents rely on for the safe and healthful care of their babies, Johnson & Johnson’s Animas unit has come under federal scrutiny by the FDA for apparently continuing to sell defective insulin pumps after Animas had become aware that the pumps were faulty.

The FDA warned J&J Animas in a December 27th letter posted online that “unless it corrects violations soon, it could face fines and other sanctions” [seizure and injunctions] “for selling faulty insulin pumps and delaying disclosures of serious injuries to patients using its OneTouch Ping and 2020 pumps.”

The FDA has ordered Animas to explain why it continued to sell the pumps when they were known to fail and to submit a plan to correct a failure to promptly report such cases in which Animas’ insulin pumps might have caused or contributed to death or serious injury. The insulin pumps, which can be programmed by a diabetic patient, are similar to the size of a cell phone, and automatically inject small amounts of insulin under the skin of the patient during the day to maintain a diabetics’ blood sugar at a safe level.

FDA inspectors found Animas had never reported one complaint it received about serious patient injury and delayed reporting two others. “Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis, caused by a lack of insulin to break down blood sugar.”

Since September 2009, approximately 30 Johnson & Johnson product recalls have been announced by the New Brunswick, New Jersey-based company. The recalls have involved products, such as Tylenol, Motrin and other nonprescription medicines for children and adults, as well as prescription drugs for seizures and HIV, faulty hip implants and contact lenses.

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  1. Joan says:
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    I wear an ANIMAS ( writer may want to make sure the subject of the article is spelled correctly) and the only time I have ever had any difficulty with the Pump it was due to my own stupidity. NO pump can be made stupid prOof, just like any car. It cannt be assumed the pumps FAILED until seeing the history of the dozing. Even then, if a pump user told the pump what to do or not to do, it’s operator error.
    I truly hope the government, in it’s desire to Protect me from myself, does not commandeer my pump. With my pump I have gotten much better control and have stopped the progression of complications. There will always be a fraction of the population who are dangers to themselves, no matter what.