FDA-Drug2026-10-27Class IIPROCESSING DEFECT

Wechem Hand Guard 1000mL bags recalled over manufacturing violations

OTHERNationwide distributionDrugs

What this means

ABC Compounding Co., Inc. is recalling about 5,800 units of Wechem Hand Guard 1000 mL, which were distributed nationwide. The FDA lists the reason as violations of current good manufacturing practice (CGMP), which are lapses in how a product is made, tested, or handled. No injuries have been reported.

  • Check whether you have Wechem Hand Guard 1000 mL made by ABC Compounding Co., Inc. in Conyers, GA.
  • No remedy has been specified yet, so contact ABC Compounding Co., Inc. for guidance.
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The agency's original wording
Hazard

CGMP Deviations

Intended for
All ages (under 0 months)
Illnesses reported
None reported
Sold states
US Nationwide
Affected count
5800 bottles
Manufactured in
2600 Dogwood Dr Se, Conyers, Georgia, United States
Products
Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013

Products in this recall · 19

The agency lists each product in this recall separately. Check every one you might have.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2027

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