CLASS II Drug recall · Reported 31 May 2023 · FDA Enforcement Report

Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy

Central Admixture Pharmacy Services is recalling Neonatal TPN Starter, Amino Acids (Trophamine) 3%/Dextrose 5% with Calcium, distributed nationwide in the US. The recall was initiated on 28 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 37-894313, Exp 04/29/2023; 37-895257, Exp 05/04/2023; 37-897360, Exp 05/12/2023; 37-897890, Exp 05/13/2023; 37-900964, Exp 05/26/2023

Quantity recalled258 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0687-2023
FDA event ID: 92253
Recalling firm: Central Admixture Pharmacy Services, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 Apr 2023
FDA classified: 19 May 2023
Reported: 31 May 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

28 Apr 2023	Recall initiated by company
19 May 2023	Classified by FDA	+21 days
31 May 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1.

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Which lots are affected?

Lot # 37-894313, Exp 04/29/2023; 37-895257, Exp 05/04/2023; 37-897360, Exp 05/12/2023; 37-897890, Exp 05/13/2023; 37-900964, Exp 05/26/2023

Where was it sold?

Nationwide in the USA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 92253

This product is part of a recall event; the main page for the event is vasopressin added to 0.9% sodium chloride*/mL* recalled.

Reported	Class	Recall	Company	Reason	Where
31 May 2023	CLASS II	vasopressin added to 0.9% sodium chloride/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids (Trophamine) 3.5%/Dextrose recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Warm Induction 4:1 High recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	MSA 7.84% MSG 8.56% (0.92M) Comp recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride* (4 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	diphenhydrAMINE 50 mg added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 8:1 non-enriched recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	potassium phosphate 30 mmole added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	NORepinephrine added to dextrose 5%, 16 mg/* (64 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 4: Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	EPINEPHrine added to 0.9% sodium chloride, 4 mg/* (16 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 8:1 High Potassium/low recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride* (6 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	EPINEPHrine added to dextrose 5%, 4 mg/* (16 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Microplegia Solution, MSA/MSG 0.92 Molar with CP2D recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Transplant Solution (Plasma-Lyte A) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vasopressin added to 0.9% sodium chloride/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	heparin added to 0.9% sodium chloride*/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	HyperLyte CR Injection recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride* (4 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 4: Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Reperfusate No Potassium recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	heparin added to 0.9% sodium chloride*/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	HyperLyte CR Injection recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	norepinephrine 4 mg added to dextrose 5%*, 16 mcg/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to dextrose 5%/Lactated Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	EPINEPHrine added to dextrose 5%, 2 mg/* (8 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Modified St Thomas Solution recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Modified St Thomas Formula recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 4:1 low potassium/low recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Microplegia (MSA/MSG 0.92 Molar) recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	NORepinephrine added to 0.9% sodium chloride, 8 mg/* (32 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to dextrose 5%* (6 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Modified St Thomas Formula recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids (Trophamine) 4%/Dextrose recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	PHENYLephrine added to 0.9% sodium chloride, 40 mg/* recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to Lactated Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	NORepinephrine added to 0.9% sodium chloride, 16 mg/* recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Reperfusate 4:1 low potassium/low recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to Lactated Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to Lactated Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to Lactated Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	potassium phosphate 15 mmole added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Microplegia Solution, High Potassium (100 mEq) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride, 750 mg/* (3 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	heparin added to 0.9% sodium chloride/*/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	phenylephrine 50 mg added to 0.9% sodium chloride, 200 mcg/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride* (5 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	diphenhydrAMINE 25 mg added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids (Trophamine) 2%/Dextrose recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 4:1 Plasmalyte recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride* (3.5 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to dextrose 5%* (5 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	PHENYLephrine added to 0.9% sodium chloride, 10 mg/* (40 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Reperfusate No Potassium recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vasopressin added to 0.9% sodium chloride/mL in Partial Additive recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	NORepinephrine added to 0.9% sodium chloride, 4 mg/* (16 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to dextrose 5%/Lactated Ringer's recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Lidocaine 2% HCl Inj recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	EPINEPHrine added to dextrose 5%, 8 mg/* (32 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	dilTIAZem added to dextrose 5%, 125 mg/* (1 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Sodium Phosphates Injection 4 mEq/3 mMol/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	PHENYLephrine added to 0.9% sodium chloride, 25 mg/* recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Potassium Acetate Injection, 2 mEq/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	vancomycin added to 0.9% sodium chloride* (3 mg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Maintenance 8:1 non-enriched recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	heparin added to 0.9% sodium chloride*/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Induction 4:1 Plasmalyte recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	tromethamine 0.3 Molar syringe recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	oxyTOCIN added to 0.9% sodium chloride recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, Modified St Thomas Solution recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023	CLASS II	Cardioplegia Solution, del Nido Formula recalled	Central Admixture Pharmacy Services	Sterility	Nationwide

More recalls from Central Admixture Pharmacy Services

All 347

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS III	Total Parental Nutrition - Pediatric PN Patient-Specific recalled	Central Admixture Pharmacy Services	Packaging Defects	GA
1 Jul 2026Drug	CLASS II	Total Parental Nutrition - Pediatric PN Patient-Specific recalled	Central Admixture Pharmacy Services	Packaging Defects	MA
19 Mar 2025Drug	CLASS I	PHENYLephrine added to 0.9% sodium chloride, 40 mg/* (160 mcg/mL) recalled	Central Admixture Pharmacy Services	Particulate Matter	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in dextrose 5%, 3 mg/, (0.1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 1,000 mcg/, (10 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide