FDA Recall
Terminated
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Recall: Z-2249-2016
·
Initiated May 20, 2016
Recall
- Recall Number
- Z-2249-2016
- Event Number
- 74249
- Firm
- Amerx Health Care Corp.
- FEI Number
- 1000525408
- Product Code
- KMJ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 20, 2016
- Terminated
- December 14, 2016
- Address
- 1300 S Highland Ave, Clearwater, FL, 33756-6519
Description
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Reason
Product did not meet specifications for Zinc Acetate (OOS).
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 [email protected].
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.
Quantity
6,993 Units