SECOND WIPE-MAKER ISSUES RECALL AFTER BACTERIA DETECTED

NON-STERILE WIPES RECALLED ON SEPTEMBER 16, 2011 FOLLOWING DISCOVERY OF LOW LEVELS OF BACILLUS CEREUS

COMMENT

Bacillus cereus was recently identified within non-sterile alcohol prep wipes manufactured by Professional Disposables International Inc (PDI), Orangeburg, NY.  The recall of five lots are similar to the recalls of sterile and non-sterile wipes from H & P Industries (Triad Group).  The gauze used to prepare both companies wipes originated with Tudor Converted Products Inc of Summerville, S.C. 

USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, which discusses problems associated with “specified” microorganisms in both sterile and non-sterile products as well as 21 CFR 211.113(a) states that appropriate written procedures, designed to prevent objectionable (specified) microorganisms in drug products not required to be sterile, shall be established and followed. Both of these documents have recently seen much use within CDER with microbiological issues.  Please visit my Blog for other recent examples and visit the article by JoNel Aleccia below. 

By JoNel Aleccia Health writer

msnbc.com

updated 9/20/2011 7:44:44 PM ET 2011-09-20T23:44:44

A second company that makes and distributes alcohol prep wipes to prevent infection has issued a large recall because of potential bacterial contamination. The firm shares a common supplier with a Wisconsin wipe-maker whose products have been blamed for illnesses and death, a spokeswoman said.

Professional Disposables International Inc., or PDI, of Orangeburg, N.Y., has voluntarily recalled all lots of five different kinds of packages of non-sterile alcohol prep pads because of what a company spokeswoman called “very low levels” of detection of Bacillus cereus bacteria.

That’s the same organism that has triggered massive global recalls, a plant shut-down and at least eight lawsuits against the Triad Group and H&P Industries of Hartland, Wis. The lawsuits claim that contaminated alcohol prep products led to dangerous infections in people using the products for medical care.

The recall announced on Sept. 16 came after federal Food and Drug Administration inspectors visited the plant and tests showed the presence of Bacillus cereus, said Melanie Liebowitz, PDI’s vice president of regulatory compliance. But she stressed that the levels were low enough that the products remained well within allowed specifications and that the recall was initiated only after extensive discussion with FDA officials.

“We’re a responsible manufacturer and we’re taking prudent action,” she said.

However, Liebowitz confirmed that the company buys padding material from Tudor Converted Products Inc. of Summerville, S.C., the same firm that supplied pad material to the Triad Group and H&P Industries. In at least one lawsuit , H&P Industries officials have claimed that the bacteria found in their products came from contaminated padding from Tudor. Both Tudor officials and Liebowitz have dismissed that notion.

FDA officials were not immediately available to comment on the recall.