Quality & complianceOfficial

FDA lists Class II recall of PRO CHEM BAN AID from Abc Compounding over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Abc Compounding Co., Inc.'s PRO CHEM BAN AID is the subject of an ongoing, nationwide Class II drug recall citing deviations from current good manufacturing practice.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report for PRO CHEM BAN AID, a product from Abc Compounding Co., Inc. The entry, dated 4 November 2026, carries recall number D-0098-2027.

The recall is attributed to deviations from current good manufacturing practice (CGMP). The status is listed as ongoing, and the product was distributed across the United States nationwide.

The source text available to us is largely the navigation and search-help content of the FDA's enforcement report database. It does not set out further details of the recall, such as the nature of the CGMP deviations, product strengths, lot numbers, quantities or the date the recall began. We have therefore not reported those points.

For context, the FDA assigns a Class II classification where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

What it means for your team

  • Quality and compliance teams at compounders and outsourcing facilities may wish to review their own CGMP controls in light of enforcement-report entries citing such deviations.
  • Distributors, pharmacies and healthcare providers that may have handled PRO CHEM BAN AID should check the full FDA enforcement record for lot and code details, which are not in the material reviewed here.
  • Because the recall is ongoing and nationwide, the scope and status could change; teams should monitor updates to recall D-0098-2027.

Official source: FDA enforcement report ↗

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

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