Quality & complianceOfficial

FDA lists Class II recall of Certus Medical Satin Foam from Abc Compounding over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The recall of Certus Medical Satin Foam, entered in FDA's enforcement report on 4 November 2026, is ongoing and covers nationwide US distribution.

The US Food and Drug Administration has published a Class II drug recall for Certus Medical Satin Foam in its enforcement report dated 4 November 2026. The recalling firm is Abc Compounding Co., Inc.

The recall is numbered D-0088-2027 and is classified as a Class II action. The stated reason is deviations from current good manufacturing practice (CGMP). The status is listed as ongoing, and the product was distributed nationwide across the United States.

The text available for this item is the enforcement report's search interface, not the full recall record. It therefore does not give the product's lot numbers, quantities, dates of manufacture, or details of the specific CGMP deviations. It also does not say how many units are affected or whether any adverse events have been reported.

By way of context, FDA defines a Class II recall as one involving a product that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

What it means for your team

  • Quality teams should check the full FDA enforcement report entry for D-0088-2027 for lot and code details, as these are not in the material reviewed.
  • Compounding and outsourcing facilities can treat the entry as a reminder that CGMP deviations can lead to nationwide recalls.
  • Distributors and healthcare providers holding Certus Medical Satin Foam should verify whether their stock falls within the recall's scope.
  • Because the recall is ongoing, its status and scope may change as the enforcement report is updated.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →