FDAFDA · Food and drugs·Recall number Z-1993-2014
Amerigel Wound Dressing 55 gallons/drum
Published July 16, 2014 · Recall initiated: March 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Kova Laboratories, Inc.
- Distributor
- Distributed in the states of FL and NJ.
- Lot
- Lot #3WD05.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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