CLASS II Drug recall · Reported 6 Sep 2023 · FDA Enforcement Report

dilTIAZem 125mg/ (1 mg/mL), added to dextrose 5%, IV recalled

Central Admixture Pharmacy Services is recalling dilTIAZem 125mg/ (1 mg/mL), added to dextrose 5%, IV, distributed nationwide in the US. The recall was initiated on 17 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 36-260048, Exp 9/13/2023; 36-262174, Exp 9/15/2023; 36-262523, Exp 9/19/2023. ;

Quantity recalled703 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-1138-2023
FDA event ID: 92898
Recalling firm: Central Admixture Pharmacy Services, Phoenix, AZ
Classification: Class II
Status: Terminated
Recall initiated: 17 Aug 2023
FDA classified: 28 Aug 2023
Reported: 6 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Blood Pressure Medication

Timeline

17 Aug 2023	Recall initiated by company
28 Aug 2023	Classified by FDA	+11 days
6 Sep 2023	Published in enforcement report	+9 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:Lack of validation data for sanitization cycles

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

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Which lots are affected?

Lot# 36-260048, Exp 9/13/2023; 36-262174, Exp 9/15/2023; 36-262523, Exp 9/19/2023. ;

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

31 other products · FDA event 92898

This product is part of a recall event; the main page for the event is EPINEPHrine added to dextrose 5%, 4mg/ (16 mcg/mL), IV recalled.

Reported	Class	Recall	Company	Reason	Where
6 Sep 2023	CLASS II	EPINEPHrine added to dextrose 5%, 4mg/ (16 mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	heparin added to 0.9% sodium chloride/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	PHENYLephrine added to 0.9% sodium chloride 50 mg/ (200mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution, High K, Induction 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	oxyTOCIN added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	PHENYLephrine added to 0.9% sodium chloride, 20mg/ (80 mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	PHENYLephrine, added to 0.9% sodium chloride, 10mg/ (40mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	dilTIAZem 125mg/ (1 mg/mL), added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution, 25 mEq K, Sutter Cardioplegia recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	vancomycin added to 0.9% Sodium Chloride (5 mg/mL) Excel recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution, 60 mEq K, Induction 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	oxyTOCIN added to Lactated Ringer's, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	oxyTOCIN added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	PHENYLephrine 1,000 mcg/, (100mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	rocuronium 50 mg/ (10 mg/mL) Syringes recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	PHENYLephrine, added to 0.9% sodium chloride, 40mg/ (160mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution del Nido Formula, Total Volume =, EVA recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution, 20 mEq K, Maintenance 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution, 24 mEq K, Maintenance 8:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	EPINEPHrine added to 0.9% sodium chloride, 4mg/ (16 mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023	CLASS II	Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy	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

Other Diltiazem recalls

All 36

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide