Recall Z-2112-2014 ยท FRO Dressing, Wound, Drug
Wellspring Pharmaceutical Corporation
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
| Date | Jul 29, 2014 (initiated Mar 25, 2014) |
| Status | Terminated |
| Reason | Potential for microbial contamination of the product. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123113 | L.A.M. IMP WOUND GEL Glycobiosciences, Inc., Dec 11, 2012 |