Examining Medical Device Recalls

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.”

Mislabeled Overpouch Prompts Recall of One Lot of Potassium Chloride Injection

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 Recalled

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. 

B. Braun Medical Inc. Issues Recall Due To Particulate Matter

B. Braun Medical Inc. is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level.

JCB Labs Recalls Drug Product Lots Due To Sterility Concerns

WICHITA, Kan. [Targeted News Service] -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following recall notice:

Aidapak Services Initiates Recall Over Possibly Incorrect Labeling

Aidapak Services LLC is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company’s website.

Birth-control Pill Mishap Leads to Lawsuits, Baby Boom

In the aftermath of a pharmaceutical packaging error, patients are giving birth to surprise babies, and some are litigating.

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.

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Novartis Consumer Health Recalls Certain Lots of Triaminic and Theraflu, Concerned about Child Resistance

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 Recalls Zicam Due to Bacterial Contamination

The makers of the liquid nasal gel, used as a decongestant, are recalling one lot of the 0.5-oz spray bottles.

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.

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Resource Maintenance Software to Aid Manufacturers in Preventing Recalls

Valdata has launched a campaign to help manufacturers and pharmaceutical packaging partners to manage maintenance and avoid recalls.

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.

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