Food, drugs, devices › Pharmedium Services, LLC

Drug recall: HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.

FDA enforcement event 78828 · Class II · initiated 27 Dec 2017 · status Terminated · terminated 7 May 2020

DrugVoluntary: Firm initiated42 product recordsLake Forest, IL

Pharmedium Services, LLC (Lake Forest, IL) initiated this drug recall on 27 Dec 2017; FDA lists 42 product records under event 78828, 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. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 7 May 2020. Initiation: voluntary: firm initiated. Pharmedium Services, LLC has 30 enforcement events on this register, with a median of 2 product records 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

Pharmedium Services, LLC, Lake Forest, IL.

Reason for recall

"Lack of sterility assurance."

Distribution

"U.S.A. Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0428-2018	HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0429-2018	Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.	297 bags	Class II	Terminated	28 Feb 2018
D-0430-2018	Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0431-2018	Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0432-2018	Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0433-2018	HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0434-2018	Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0435-2018	Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0436-2018	Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0437-2018	Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0438-2018	Lidocaine HCl in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0439-2018	Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0440-2018	Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0441-2018	Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0442-2018	Succinylcholine Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0443-2018	Adenosine Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0444-2018	Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0445-2018	Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0446-2018	Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0447-2018	Labetalol HCl in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0448-2018	Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0449-2018	Midazolam HCl Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0450-2018	Fentanyl Citrate Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0451-2018	Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0452-2018	Ketamine HCl Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0453-2018	Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0454-2018	Glycopyrrolate in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0455-2018	Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0456-2018	Atropine Sulfate Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0457-2018	HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0458-2018	Ropivacaine HCl Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0459-2018	Nicardipine HCl in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0460-2018	Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0461-2018	Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0462-2018	Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0463-2018	Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0464-2018	Esmolol HCl in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0465-2018	Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0466-2018	Methadone HCl Injection in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0467-2018	Rocuronium Bromide in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0468-2018	Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018
D-0469-2018	Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.	Unknown	Class II	Terminated	28 Feb 2018

Context

57%of 2017 drug events are Class II343 events that year

42product records in this eventfirm median: 2

30events on this register for the firm

Other enforcement events for Pharmedium Services, LLC

Initiated	Product (first record)	Type	Class	Records
16 Mar 2020	ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free Pha	Drug	Class II	13
16 Dec 2019	NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex	Drug	Class III	3
7 Jun 2019	Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, M	Drug	Class I	1
2 Jan 2019	0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% B	Drug	Class II	1
5 Dec 2018	Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL tot	Drug	Class II	2
24 Jul 2018	10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fenta	Drug	Class II	3
5 Jun 2018	HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC	Drug	Class II	1
10 Apr 2018	Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services	Drug	Class III	1
5 Feb 2018	15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC	Drug	Class II	3
30 Oct 2017	ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packag	Drug	Class II	1

All 30 events for Pharmedium Services, LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of sterility assurance."

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.A. Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 May 2020. "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.