J&J's Ethicon recalls blood-stopping hemostat; FDA warns of deadly risk

Johnson & Johnson unit Ethicon is recalling its some of Surgiflo hemostatic kits, warning that a packing issue could lead to breaches in the product, and the FDA has assigned its most serious label to the recall.

Surgiflo is a topical, absorbable hemostat used to stop bleeding in surgical procedures. Ethicon became aware of the packing problem back in the spring and is urging customers to return the affected lots once they're identified. The FDA has branded the affair a Class I recall, saying the recalled products could be rendered non-sterile and their use could to lead to serious injury or death.

Ethicon says it is yet to receive any reports of adverse events from Surgiflo, but the FDA is asking customers to report any problems through its online MedWatch system.

Ethicon has a long history of regulatory dustups, including the costly and deadly vaginal mesh debacle and an October Class I over malfunctioning surgical staplers. However, the company last week won FDA approval for its Evarrest Fibrin Sealant Patch, and J&J has committed to spending $185 million to expand Ethicon's suture-making plant in Athens, GA.

- Here's the FDA's notice

FDA: J&J Unit (Synthes) Recalls Potentially Flammable Bone Putty

The health regulator said certain lots of bone putty made by Johnson &Johnson unit Synthes were recalled as there was potential for the putty to catch fire if it came in contact with electrosurgical cautery systems during surgery.

The Hemostatic Bone Putty is used to stop bone bleeding by creating a physical barrier along the edges of bones damaged by trauma or cut during a surgical procedure.
The recall, which has been classified as Class I, or the most serious type of recall, was initiated on July 5.
Synthes had issued a medical device recall letter on July 5 requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the putty manufactured between July 6, 2011 and December 14, 2011.Synthes has been in the news for all the wrong reasons, Symthes is unusual in that it is one of a few cases in which company execs have been sentenced to a term of imprisonment for a misdemeanor violation of the Food, Drug and Cosmetic Act. The individual defendants, by virtue of their jobs, were “responsible corporate officers” at various time during the circumstances surrounding the clinical trial that was described in the indictment.


And what exactly took place? From May 2002 until fall 2004, a Synthes subsidiary called Norian, as well as Synthes and the former execs, ran unauthorized trials of their Norian XR and Norian SRS devices, which were bone cements used in surgeries to treat vertebral compression fractures of the spine, or VCR, a painful condition commonly suffered by the elderly, according to the feds.


The surgeries were performed despite a warning on the FDA labeling for Norian XR that cautioned against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine, according to the feds. But they apparently disregarded the warnings. For instance, the feds say that, before the marketing program began, pilot studies showed the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research conducted in a pig also showed that such cement-caused clots became lodged in the lungs.


Just the same, the Synthes gang marketed the device for VCFs without conducting testing that needed FDA approval, the marketing did not stop until after a third patient had died on the operating table.The trials were conducted at various US hospitals and selected surgeons were approached during so-called ‘Test Market Kick-Off’ meetings and a forum in 2003 and early 2004, according to the feds, who say about 52 spine surgeons were trained.


What’s more, after the death of that third patient in January 2004, they did not recall Norian XR from the market – which would have required them to disclose details of the three deaths to the FDA, according to the feds. Instead, they “compounded their crimes by carrying out a coverup in which they made false statements to the FDA during an official inspection in May and June 2004.” However since the purchase by J&J, it is J&J who now hold the legal burden.

To date:

2011 - Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. All four plead guilty to one misdemeanor count of shipping an adulterated and misbranded product in interstate commerce.Thomas Higgins, 55, a former president of the Synthes spine division, and Michael Huggins, 54, a former president of Synthes North America, were each sentenced to nine months. John Walsh, 48, who was director of regulatory and clinical affairs, was sentenced to five months. Richard Bohner, 57, sentenced at a later date to 8 months. Each must also pay a $100,000 fine. 

Feb, 2012 - FDA Warning Letter 

Latest 2012 - FDA: J&J Unit Recalls Potentially Flammable Bone Putty

3 Chinese drug makers recall 13 chromium-tainted (porcine)gelatin products

Three pharmaceutical companies have recalled their chromium-contaminated drug capsules after authorities suspended sales of 13 types of problematic medicines.
Tonghua Yason Pharmaceuticals in Northeast China's Jilin province said the company decided to recall all tainted products made since 2010.
"Pharmaceutical producers do not possess the capability to examine capsules, so we just simply checked the quality report provided by capsule suppliers and then let them go," an anonymous official with the company's product quality department was quoted as saying by stcn.com, a website run by Securities Times.
But the company said the producer of the problematic capsules was a Zhejiang-based company and was not among those exposed by media.
China Central Television revealed in an investigative program on Sunday that nine pharmaceutical companies were packaging medicines with capsules made with industrial gelatin, which contains a much higher degree of chromium than edible gelatin.
The industrial gelatin was made from waste leather at plants in Jiangxi, Zhejiang and Hebei provinces, according to the report. (Pictured above:  Huge piles of substandard leather scraps at the warehouse of Xueyang Gelatin and Glair Factory in Hengshui, Hebei province, were used to make gelatin that was sold to capsule makers. Wang Min / Xinhua).
Normally, capsules are made with material from animal bones.
Excessive intake of chromium can result in chronic diseases. 

Jilin-based Huinan Tianyu Pharmaceutical posted a statement on its website saying that it is recalling the batch of products exposed by CCTV, but "those products were not problematic because they were produced in 2009 and they accorded with the standards set in related code released in 2000".
The Chinese Pharmacopoeia, amended in 2010, permits no more than 2 milligram of chromium per 1 kilogram of medicine. Before that, the cap was 5 mg per 1 kg for heavy metal, but it had no specific stipulation about chromium, said the announcement.
The company's products were found with 3.54 mg of chromium per 1 kg of medicine.
Dandong Tongyuan Pharmaceutical in Northeast China's Liaoning province also announced the recall of its chromium-contaminated products, according to China News Service.
Xiuzheng Pharmaceutical Group in Jilin said in a statement on its website that the company has suspended sales of the problematic products but said "the capsule suppliers we pick are quality firms that meet all the country's standards and we are re-examining those products".
After the chromium scandal was exposed, websites for three pharmaceutical companies involved, including Xiuzheng, were hit by hackers.
Song Xunjie, a manager with Xueyang Gelatin and Glair Factory in Hebei province, was detained on Monday by police and suspected of setting fire to his factory to eliminate evidence.
The fire did not cause any casualties. The factory had suspended production and police sealed 200 tons of products there.
The factory mainly sold products in Beijing and Zhejiang, as well as cities such as Changzhou, Jiangsu province, and Xiamen, Fujian province, according to Xinhua News Agency.
Sun Zhongshi, an expert with the National Rational Drug Use Monitoring System under the Ministry of Health, said the drug watchdog paid more attention to the quality of medicine inside the capsules rather than the capsules themselves, and should draw a lesson from this scandal.

SOURCE: China Daily

Australasian alert for tainted blood

CSL contaminated batches of Albumin recalled after lengthy delays to notify.
Yesterday the Therapeutic Goods Administration (TGA) in Australia quarantined CSL Human Albumin solutions from further use while an assessment is carried out into the safety of the products.
That followed notification from CSL Biotherapies that some batches of the solutions manufactured before January 25 had been contaminated with coolant ethylene glycol, due to equipment failure.
As a result the TGA issued a recall to all hospitals throughout Australia, New Zealand, Hong Kong and Singapore for the albumin, the main protein in plasma, manufactured before January 25.
CSL had advised the TGA that levels of contamination were "very low" and adverse clinical effects appeared unlikely. So far, CSL had not found evidence of anyone who received the albumin suffering ill effects. Toxicity due to ethylene glycol would occur acutely and delayed effects beyond 72 hours would not be expected.
CSL was continuing further tests ''to quantify the levels of contamination and the extent of the batches affected''.
Today a New Zealand Ministry of Health spokesman said CSL had not yet identified any batches of albumin in the country that were affected, but testing was continuing.
Hospitals had been advised and were working with the New Zealand Blood Service to manage use of the existing stock.
The ministry was also "promptly" sourcing stock it could be sure of.
In Australia, the TGA said that as a result of the action to quarantine stocks, supplies of albumin may be limited in the immediate future.
Stocks in Australia were being quarantined from further use until safety implications had been fully assessed.
Advice released by the TGA last night on the effect of ethylene glycol said ingestion of the coolant could lead to acute renal failure and trigger symptoms consistent with alcohol intoxication.
The highest risk would be anticipated among those patients requiring the largest volumes of albumin.

Marketing of Trasylol Suspended

Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.