FDA (Devices) recall action 68488
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Kova Laboratories is recalling Amerigel Wound Dressing 1 oz. tubes because they may not have been manufactured pursuant to a validated process protocol and CGMP.
Kova Laboratories is recalling 3 drums of Amerigel Wound Dressing because the product may not have been manufactured according to validated protocols and CGMP.