FDA-Drug2026-07-29Class IIPROCESSING DEFECT

Fresenius Kabi glycopyrrolate injection recalled for hair contamination

Nationwide distribution

Fresenius Kabi glycopyrrolate injection recalled for particulate contamination

Hair was found in some vials of Fresenius Kabi glycopyrrolate injection. The affected product is a prescription medication used during anesthesia and medical procedures. Two lots distributed nationwide are involved.

  • Check vials for lot numbers 6134349 or 6134620 (expiration 11/2026)
  • Do not use affected vials; quarantine them
  • Contact Fresenius Kabi or your pharmacy for replacement product
  • Notify your healthcare provider if you received an injection from an affected vial
Hazard

Presence of Particulate Matter: Hair was found in product

Sold states
Nationwide within in the USA
Affected count
59,425 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2026

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