Microbial Contamination Leads to IPM Wound Gel Recall
Some wound gels used in hospitals throughout the United States may have microbial contamination, which could lead to serious adverse consequences for patients, including death, federal regulators warn.
The FDA issued a class 1 recall for one lot of IPM Wound Gel on August 12, indicating that the product may be contaminated by bacteria and could cause serious side effects, such as limb loss and death. No serious injuries or deaths have been reported.
IPM Wound Gel is a product primarily used in hospitals to help with serious wound care. It is used on leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds, including post-operative incisions and donor site incisions, and damaged or infected tissue, including debrided and second degree wounds.
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The recall affects IPM Wound Gel, lot #3P3446, sold in cartons of four in 10 gram tubes. The recall does not affect any over-the-counter versions.
The agency issued a recall warning after discovering one lot of the product was contaminated with bacteria, specifically the Psuedomonas Putida strain.
A class I recall is the most serious type of recall the FDA can issue. It is typically only issued when it involves the most serious and severe types of situations. These situations often have a high likelihood of causing serious side effects to patients, including the most serious, death.
IPM Wound Gel is manufactured by Sarasota, Florida based Wellspring Pharmaceutical Corporation and is distributed by Edwards Pharmaceuticals Inc. The recalled products were manufactured on November 14, 2013. The lots were distributed December 5, 2013 to February 4, 2014 and on March 12–20, 2014.
Customers are instructed to return the product to the manufacturer so it can be destroyed. Customers with questions can contact the manufacturer by calling (866) 37-4500.
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