Neonatal TPN Starter Bag recall: Sterility Concern
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0400-1.
Why was Neonatal TPN Starter Bag recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 37-895214, Exp 05/04/2023; 37-897950, Exp 05/13/2023; 37-899603, Exp 05/20/2023
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0400-1.
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 80 bags
- Distribution
- Nationwide in the USA.
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)