Health Care Professional Letter
Please refer to the FDA-approved prescribing information for the drug product listed below:
- 0.9% Sodium Chloride Irrigation, USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886f889b-f3cf-4197-b307-6cfa88c89436)
- Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
- Regular mail or Fax: Download form https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).
Reporting Adverse Events or Product Quality Issues
To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/).