Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN,...
FDA Recall #D-0698-2023 — Class II — April 28, 2023
Product Description
Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
328 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-894695, Exp 04/30/2023; 37-895693, Exp 05/05/2023; 37-900065, Exp 05/21/2023; 37-900622, Exp 05/25/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated