FDAClass IIJuly 27, 2016

Amerigel Hydrogel Wound Dressing Advanced Formula for recall

Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

Why was Amerigel Hydrogel Wound Dressing Advanced Formula for recalled?

Product did not meet specifications for Zinc Acetate (OOS).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 668

Product
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Recalling firm
Amerx Health Care Corp.
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.
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls