Pouches were the most prevalent packaging type seen in a recent study of medical device recalls associated with packaging failure. “Out of 60 packaging failure types, 36 were related to pouches, which is equivalent to 60%,” explains Eric Schmohl, customer and application support manager, Tyvek, for DuPont Medical & Pharmaceutical Protection. “All other packaging types range from one to six counts of failure.”
FDA is reporting on its Web site that Baxter International Inc. is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL because of a complaint of a mislabeled overpouch.
Convenience sterile surgical packs are being recalled after the discovery of what is being called an "adhesion defect," FDA shared via e-mail this week.
Shanta Russell had been taking her birth-control pills faithfully for more than a dozen years without a hitch. So when pregnancy tests kept turning up positive in June 2011, she was stunned.
Shock turned to anger three months later when the single Kansas City woman received a recall notice in the mail warning that the pills she had taken may have been placed in the wrong order in their blister packs. The mistake could render the pills ineffective.
Novartis Consumer Health Inc. is reporting on its Web site that it is "voluntarily recalling certain lots of Triaminic Syrups and Theraflu Warming Relief Syrups that were manufactured in the United States before December 31, 2011." The company reports that it is recalling the lots "because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place," it states on its Web site.
Matrixx Initiatives is voluntarily recalling 1 lot of Zicam® Extreme Congestion Relief nasal gel. The company is taking this step after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.
In light of the increasing number of manufacturer recalls, Valdata Systems has launched a campaign focusing on educating manufacturers on ways to ensure proper maintenance of equipment and prevent future recalls.
Valdata has developed an integrated set of modules within its Chemical Management System (“CMS”) which enforcesresource maintenance rules. The result is a higher level of protection from quality issues resulting in product recalls.