FDAClass IAugust 6, 2014

IPM Wound Gel recall: Contamination

IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

Why was IPM Wound Gel recalled?

Potential for microbial contamination of the product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #3P3446

Product
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Recalling firm
Wellspring Pharmaceutical Corporation
Quantity
3,135 cartons of 4/10g tubes
Distribution
Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.
Recall date
August 6, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
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