The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0693-2023·Announced 2023-05-31

FDA Recalls Neonatal TPN Starter Bags for Sterility Concerns

Central Admixture Pharmacy Services recalls 747 bags of Neonatal TPN Starter Bags due to FDA sterility concerns. Products were distributed nationwide across the USA.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (intravenous nutrition for vulnerable neonates) where no illnesses or injuries have been reported. The lack of sterility assurance in an injectable product intended for vulnerable patients represents significant potential for infection.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 747 bags of Neonatal TPN Starter Bag (Amino Acids [Trophamine] 4% / Dextrose 10% with Calcium and Heparin, 250 mL per bag, NDC 71285-0422-1) distributed nationwide. The recall was initiated following an FDA inspection that called into question the sterility assurance of these intravenous nutrition products.

The affected lots with their expiration dates are: 37-893819 (04/28/2023), 37-894702 (04/30/2023), 37-894710 (04/30/2023), 37-895215 (05/04/2023), 37-897282 (05/12/2023), 37-897921 (05/13/2023), 37-898309 (05/14/2023), 37-899199 (05/19/2023), and 37-900058 (05/21/2023). The products are manufactured by Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Allentown, Pennsylvania 18106.

Healthcare providers and patients should verify whether they have received any of these recalled products. These are prescription-only products intended for intravenous use in neonatal patients. If any of the affected lots have been dispensed, they should not be used. Patients and healthcare providers should contact their healthcare provider or the manufacturer with questions or concerns.

The recalled product

Product
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.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition
Hazard
Affected units
747

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

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Same manufacturer · Central Admixture Pharmacy Services, Inc.

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