Recall Z-2249-2016 ยท KMJ Lubricant, Patient
Amerx Health Care Corp.
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
| Date | May 20, 2016 |
| Status | Terminated |
| Reason | Product did not meet specifications for Zinc Acetate (OOS). |
| Root cause | Other |
| Action | Initial recall notification was sent to distributors, informing them of the voluntary recall and providing instructions on expanding the recall to the wholesale level. Distributors were instructed to identify recalled product in their inventory, quarantine any recalled product, and to complete and fax back a Recall Response Form. Contact information was provided for those with questions: 1-800-448-9599 and recall@amerxhc.com. |
| Quantity | 6,993 Units |
| Distribution | AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970133 | AMERIGEL OINTMENT Amerx Health Care Corp., Apr 14, 1997 |