When you make drugs or other medical products, unwanted contaminants can fall into the mix — say, beetle parts (in baby formula) or glass flakes (in anemia drugs). The latest pharma world example of wow-that-really-shouldn’t-be-in-there comes from Merck. As the WSJ reports , the company says charred bits of plastic shrink wrap have been found in vials of vaccines made at a big plant in West Point, Pa. Affected products include Gardasil, used against the human papillomavirus, as well as shots against shingles, measles/mumps rubella, pneumococcal disease and chicken pox. How’d this happen? It seems pieces of the wrap weren’t removed during vial washing and were charred during a sterilization process. Merck says there are no reports of adverse health problems, though theoretically the particles could cause a reaction at the injection site. The problem is very rare, according to the company. The FDA has been tracking problems at the plant since 2008, according to the WSJ. A series of inspection reports have chronicled the issues — most of which

have been resolved, Merck says. Here they are: An April 2011 report cited the shrink-wrap particles, saying there were a dozen company-submitted reports about the problem since November, 2009 — eight due to customer complaints. The report noted that while plastic boxes replaced shrink-wrapped vials in some cases, some product vials were still being shipped in the wrap, raising the possibility of further problems. (Merck tells the WSJ it will end the use of shrink wrap on incoming vials by the end of the year.) A report from August, 2010 , found that an undisclosed number of adverse event reports involving drugs made at the plant weren’t submitted to the FDA in a timely fashion — that is, within 15 days. An inspection report from January and February of 2009 identified problems including stainless steel particles in certain vaccines and a treatment for black widow spider bites, and cracked vaccine vials. Image: Associated Press

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Charred Shrink Wrap in Merck Vaccines: Read the FDA Inspection Reports