Quality & complianceOfficial

FDA classifies Abc Compounding's Wechem Hand Guard bag recall as Class II over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The nationwide recall of Wechem Hand Guard 8/1000mL Bag, recorded as D-0103-2027, is listed as ongoing in the FDA enforcement report dated 4 November 2026.

The US Food and Drug Administration has published a Class II drug recall in its enforcement report for Wechem Hand Guard 8/1000mL Bag, a product from Abc Compounding Co., Inc. The entry is dated 4 November 2026 and carries recall number D-0103-2027.

The recall is attributed to deviations from current good manufacturing practice (CGMP). The record on file gives the product name and this reason category only; the available text does not explain which CGMP requirements were not met.

The FDA lists the recall status as ongoing, and distribution is described as US nationwide. The material provided does not include lot numbers, quantities, dates of manufacture or the date the recall began, so the affected batches cannot be identified from this item.

By way of context, the FDA applies Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Compounders and outsourcing facilities should treat this entry as a reminder that CGMP deviations can lead to a nationwide recall, even without a stated safety event.
  • Distributors and pharmacies handling Wechem Hand Guard should check the full FDA enforcement report entry for lot and code details before acting.
  • Quality teams should note that the recall is ongoing, so scope and recall details may still change.

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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