Class II
Terminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1.
- Recall Initiated
- April 28, 2023
- Posted
- May 31, 2023
- Recall Number
- D-0700-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 175 bags
- Firm Location
- Allentown, PA, United States
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot # 37-894962, Exp 05/01/2023; 37-898285, Exp 05/14/2023
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