IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination

[Posted 08/12/2014]

AUDIENCE: Dermatology, Risk Managers, Surgery, Endocrinology, Nursing

ISSUE:  IPM Wound Gel Lot # 3P3446 by Wellspring Pharmaceutical Corporation and distributed by Edwards Pharmaceuticals Inc. is being recalled. The lot of IPM Wound Gel may be contaminated with bacteria (Pseudomonas Putida). IPM Wound Gel is used primarily in hospitals for wound care; the over-the-counter IPM Wound Gel is not included in this recall.

BACKGROUND:  The product was manufactured on November 14, 2013 and distributed between December 5, 2013 – February 4, 2014 and March 20-12, 2014.  IPM Wound Gel is supplied in cartons of four 10g tubes.

RECOMMENDATION: Customers should return the affect products for destruction to the firm and notify any customers who received the product through redistribution. Customers with questions about this recall may contact the firm at 1-866-337-4500, Monday through Friday, 8:30 a.m. - 4:30 p.m., Eastern Time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/12/2014 - Recall Notice - FDA]