FDA-Drug2026-09-09Class IIPROCESSING DEFECT

Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations

OTHERNationwide distributionDrugs

What this means

Baxter Healthcare Corporation is recalling a specific lot of Clindamycin Phosphate in 0.9% Sodium Chloride Injection due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lot (NC193689, expiring 10/16/2027) was distributed nationwide, as well as to Puerto Rico and Chile.

  • If you have this medication, contact your pharmacy or healthcare provider immediately with the lot number.
  • Do not use this lot. Return it to your pharmacy or follow your healthcare provider's instructions for safe disposal.
  • Ask your healthcare provider about alternative treatment options if you need this medication.
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
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0816-2026

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