Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
This recall has been terminated (originally issued May 20, 2016).
- Company
- Amerx Health Care Corp.
- Recall Initiated
- May 20, 2016
- Terminated
- December 14, 2016
- Recall Number
- Z-2249-2016
- Quantity
- 6,993 Units
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Product did not meet specifications for Zinc Acetate (OOS).
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.
Lot / Code Info
Lot # 668
Root Cause
Other
Action Taken
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.
More recalls by Amerx Health Care Corp.
Amerigel Post-op Surgical Kits
Wound management
Dec 4, 2014
Amerigel Daily Dressing Packets
Wound management
Dec 4, 2014