Z-2112-2014Class I

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

Name: Z-2112-2014 IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing
Creator: Wellspring Pharmaceutical Corporation
Published: 2014-03-25
License: https://open.fda.gov/license/

Wellspring Pharmaceutical Corporation / initiated 2014-03-25 / Terminated / root cause: manufacturing process

FDA source

Wellspring Pharmaceutical Corporation began a recall of IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing on 2014-03-25. FDA classified it as Class I and gives the reason as "Potential for microbial contamination of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2112-2014
Classification: Class I
Status: Terminated
Initiated: 2014-03-25
Posted: 2014-07-29
Terminated: 2014-09-08
Recalling firm: Wellspring Pharmaceutical Corporation
Product: IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Potential for microbial contamination of the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 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.
Product codes and lots: Lot #3P3446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2112-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2112-2014	Class I	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29

Product code FRO

K123113UnclassifiedL.a.m. Imp Wound GelGlycobiosciences, Inc. / cleared 2012-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)