Class II Recall

Central Admixture Pharmacy Services, Inc.

Product
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
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 # 37-894695, Exp 04/30/2023; 37-895693, Exp 05/05/2023; 37-900065, Exp 05/21/2023; 37-900622, Exp 05/25/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Central Admixture Pharmacy Services, Inc. — Class II Recall | MedicineWatch US