Food, drugs, devices › Fresenius Kabi USA, LLC

Drug recall: MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Sch

FDA enforcement event 63451 · Class II · initiated 27 Sep 2012 · status Terminated · terminated 12 Dec 2014

DrugVoluntary: Firm initiated3 product recordsLake Zurich, IL

Fresenius Kabi USA, LLC (Lake Zurich, IL) initiated this drug recall on 27 Sep 2012; FDA lists 3 product records under event 63451, classified Class II.

FDA defines Class II as 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. 56% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 12 Dec 2014. Initiation: voluntary: firm initiated. Fresenius Kabi USA, LLC has 67 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Fresenius Kabi USA, LLC, Lake Zurich, IL.

Reason for recall

"Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles."

Distribution

"U.S. Nationwide Including Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0295-2015	MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.	101,200 Vials	Class II	Terminated	17 Dec 2014
D-0296-2015	ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02	184,550 Vials	Class II	Terminated	17 Dec 2014
D-0297-2015	CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.	240,550 Vials	Class II	Terminated	17 Dec 2014

Context

56%of 2012 drug events are Class II209 events that year

3product records in this eventfirm median: 1

67events on this register for the firm

Other enforcement events for Fresenius Kabi USA, LLC

Initiated	Product (first record)	Type	Class	Records
10 Aug 2026	Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, L	Drug	Class I	1
4 Aug 2026	Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenou	Drug	Class I	1
16 Jul 2026	Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vi	Drug	Class II	5
14 May 2026	Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696	Drug	Class III	1
6 May 2026	Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004	Device	Class I	1
6 May 2026	LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.	Device	Class I	1
11 Mar 2026	0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only,	Drug	Class II	14
4 Feb 2026	The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.	Device	Class II	1
21 Nov 2025	Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.	Device	Class II	1
14 Nov 2025	Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients	Device	Class I	1

All 67 events for Fresenius Kabi USA, LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide Including Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 12 Dec 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.