Quality & complianceOfficial

FDA lists Class II recall of PRO CHEM Fresh Start over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Abc Compounding Co., Inc. is recalling PRO CHEM Fresh Start nationwide under recall D-0097-2027, which FDA classed as Class II and still ongoing.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report for PRO CHEM Fresh Start, a product from Abc Compounding Co., Inc. The entry is dated 4 November 2026.

FDA gives the reason for the recall as deviations from current good manufacturing practice (CGMP). The recall carries the number D-0097-2027, and its status is listed as ongoing.

The product was distributed across the United States nationwide, according to the entry. The text available to VigiEye consists mainly of search-page navigation and does not include the recalled lots, quantities, dosage form, recall initiation date or details of the specific CGMP failures.

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

What it means for your team

  • Compounders and outsourcing facilities should treat CGMP-related recalls as a reminder to review their own manufacturing and quality-system controls.
  • Distributors and pharmacies that handled PRO CHEM Fresh Start should check the full FDA enforcement report entry for lot information and recall instructions.
  • Quality and regulatory teams should note the recall remains ongoing, so further updates to its status are possible.

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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