Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with 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 71285-0416-1.
Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification
Class II
Status
Terminated
Lot
Lot # 37-897800, Exp 05/12/2023; 37-897895, Exp 05/13/2023
Date
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