Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads

Hepatitis C Medicines

Triad Pads Packaged with Pegasys In The U.S.

Genentech, Inc., a member of the Roche Group distributed the Triad pads packaged with Pegasys; "The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines, Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase to customers in the United States."

Merck

PEGINTRON single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A Multidose RediPen® and INTRON®= "Merck medicines distributed in the "United States" are not impacted by the Triad Group recall".

U.S. Merck issued a warning on Jan. 23, 2011 - Merck (known as MSD outside the United States and Canada) has become aware of the market recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by the Triad Group in the United States. The Triad Group recall impacts the alcohol prep pads that are co-packaged and distributed with the Merck medicines PEGINTRON® (peginterferon alfa-2b) single dose RediPen® and PEGINTRON® vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and INTRON® A (interferon alfa-2b) Multidose RediPen® and INTRON® A Solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad Group recall.

Upon discussion and agreement with local Ministries of Health, Merck will begin packaging orders without alcohol prep pads until a suitable alternative has been identified.

It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded.

Reported allegedly after using a Triad pad packaged with (Pegasys) peginterferon alfa-2a

Medpage;@ MSNBC also reported that a 55-year-old Tennessee man who contracted endomyocarditis, allegedly after using a Triad pad packaged with Genentech's peginterferon alfa-2a drug for hepatitis C. The man survived but required cardiac valve replacement surgery in December. He too has filed suit against Triad, with Genentech also named as a defendant".

FDA Recall
Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.

.. See; Triad: Drug Recall Notice
Group's customer service hotline at (262) 538-2900.

Reported @ MSNBC
MSNBC has reported the sad story of the Kotharis family who believe alcohol swabs made by TRIAD Group, Inc., were to blame for the death of their two year old son. The child Harrison Kothari, died from a rare infection blamed on the wipes; which were allegedly contaminated with a bacteria called bacillus cereus.

The hospital Children’s Memorial released this statement "Children’s Memorial Hermann Hospital is deeply saddened by the death of any child in our care," it read. "Memorial Hermann was notified of the product recall in January, one month after this child died. At that time, the product was removed from our shelves. We are dedicated to providing the highest standard of quality care and patient safety at Children’s Memorial Hermann Hospital."

Triad Alcohol Pad Recall Announced on Good Morning America

..

Reported By MSNBC

Problems with sterilization, contamination

Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.

Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.
The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity.

In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.
“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,” the report said.

In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said.

The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.
However, inspectors said Triad’s processes “may not be adequate to sterilize” the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels” previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents. Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution.

In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, David Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.
“No action was taken on the distributed cases,” inspectors wrote.
Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….

Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, Kelly said.

From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which Kelly said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.

Source; MSNBC