FDAFDA · Food and drugs·Recall number D-0693-2023
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/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 71285-0422-1.
Published May 31, 2023 · Recall initiated: April 28, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- Lot # 37-893819, Exp 04/28/2023; 37-894702, 37-894710, Exp 04/30/2023; 37-895215, Exp 05/04/2023; 37-897282, Exp 05/12/2023; 37-897921, Exp 05/13/2023; 37-898309, Exp 05/14/2023; 37-899199, Exp 05/19/2023; 37-900058, Exp 05/21/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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