Food, drugs, devices › Pharmedium Services, LLC

Drug recall: 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

FDA enforcement event 81730 · Class II · initiated 5 Dec 2018 · status Terminated · terminated 2 Oct 2020

DrugVoluntary: Firm initiated2 product recordsLake Forest, IL

Pharmedium Services, LLC (Lake Forest, IL) initiated this drug recall on 5 Dec 2018; FDA lists 2 product records under event 81730, 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 2 Oct 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

"Sub-potent"

Distribution

"Nationwide in the USA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0333-2019	Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.	295 50 ml in 60 ml syringes	Class II	Terminated	26 Dec 2018
D-0334-2019	Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48	295 100 mL in 150 mL Intravia bags	Class II	Terminated	26 Dec 2018

Context

60%of 2018 drug events are Class II367 events that year

2product 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
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
27 Dec 2017	HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.	Drug	Class II	42
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: "Sub-potent"

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: "Nationwide in the USA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Oct 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.