FDA-Drug2026-09-09Class IIPROCESSING DEFECT

Baxter Daptomycin injection recalled for manufacturing quality deviations

OTHERNationwide distributionDrugs

What this means

Baxter Healthcare is recalling one lot of Daptomycin in 0.9% Sodium Chloride Injection due to deviations from current good manufacturing practice (CGMP) standards during production. The affected lot (NC193856, expiring 04/18/2028) was distributed nationwide, Puerto Rico, and Chile.

  • Check your pharmacy records or hospital inventory for Daptomycin lot NC193856.
  • Do not use this lot. Quarantine and return it to your supplier or Baxter.
  • Contact your healthcare provider or pharmacy if you received this lot.
The agency's original wording
Hazard

CGMP Deviations

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2026

More Baxter recalls

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