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Terminated

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

FDA Recall Z-2112-2014 · Posted 2014-07-29

Recalling FirmWellspring Pharmaceutical Corporation
Recall StatusTerminated
Product CodeFRO
Date Initiated2014-03-25
Date Terminated2014-09-08
Product Quantity3,135 cartons of 4/10g tubes

Reason for Recall

Potential for microbial contamination of the product.

Firm Action

WellSpring Pharmaceutical Corporation notified customers on March 25, 2014 via e-mail. The notification identified the affected product, the problem, and directed consignees to return all products.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123113L.A.M. IMP WOUND GELGlycobiosciences, Inc. · 2012-12-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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