Food, drugs, devices › PharMEDium Services, LLC

Drug recall: 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

FDA enforcement event 85212 · Class II · initiated 16 Mar 2020 · status Terminated · terminated 14 Feb 2025

DrugVoluntary: Firm initiated13 product recordsDayton, NJ

FDA enforcement event 85212 is a drug recall by PharMEDium Services, LLC of Dayton, NJ, initiated 16 Mar 2020 and classified Class II, with 13 product records.

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. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 14 Feb 2025. 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, Dayton, NJ.

Reason for recall

"Firm is recalling 46 lots of various products because of a lack of sterility assurance."

Distribution

"Distributed Nationwide in the US"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1081-2020	ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12	1075 units	Class II	Terminated	15 Apr 2020
D-1082-2020	nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01	80 units	Class II	Terminated	15 Apr 2020
D-1083-2020	rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10	4625 units	Class II	Terminated	15 Apr 2020
D-1084-2020	HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44	1840 units	Class II	Terminated	15 Apr 2020
D-1085-2020	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50	210 units	Class II	Terminated	15 Apr 2020
D-1086-2020	succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04	2475 units	Class II	Terminated	15 Apr 2020
D-1087-2020	rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05	2250 units	Class II	Terminated	15 Apr 2020
D-1088-2020	ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09	375 units	Class II	Terminated	15 Apr 2020
D-1089-2020	fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44	290 units	Class II	Terminated	15 Apr 2020
D-1090-2020	ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02	1500 units	Class II	Terminated	15 Apr 2020
D-1091-2020	ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09	900 units	Class II	Terminated	15 Apr 2020
D-1092-2020	fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33	75 units	Class II	Terminated	15 Apr 2020
D-1093-2020	fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28	1350 units	Class II	Terminated	15 Apr 2020

Context

64%of 2020 drug events are Class II342 events that year

13product 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 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
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: "Firm is recalling 46 lots of various products because of a 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: "Distributed Nationwide in the US"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Feb 2025. "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.