Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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