Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
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 Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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