CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report

Fentanyl Citrate 16.67 mcg per mL recalled by Pharmedium Services

Pharmedium Services is recalling Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 17 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15

Quantity recalled210 syringes

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-0032-2017
FDA event ID: 73925
Recalling firm: Pharmedium Services, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2015
FDA classified: 12 Oct 2016
Reported: 19 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Drug class: Pain Medication

Timeline

17 Jul 2015	Recall initiated by company
12 Oct 2016	Classified by FDA	+453 days
19 Oct 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Which lots are affected?

Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15

Where was it sold?

Nationwide

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

68 other products · FDA event 73925

This product is part of a recall event; the main page for the event is morphine Sulfate, 1 mg per mL (2 mg recalled by Pharmedium Services.

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016	CLASS II	morphine Sulfate, 1 mg per mL (2 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ketamine HCl, 10 mg per mL, 50 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	HYDROmorphone HCl, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	rocuronium Bromide, 10 mg per mL, 50 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	morphine Sulfate, 2 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 2%, 20 mg per mL (60 mg per Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 10 mcg per, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 5 mcg per mL, 15 mcg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	succinylcholine Chloride Injection, 20 mg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	midazolam HCl, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 1%, 10 mg per mL (50 mg per Total Volume in a syringe recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	glycopyrrolate, 0.2 mg per mL, 0.6 mg per Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 1%, 10 mg per Total Volume in a syringe recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4% Total recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	midazolam HCl, 1 mg per mL (2 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	morphine Sulfate, 1 mg per mL (2 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 2%, 20 mg per mL (100 mg per Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	neostigmine Methylsulfate, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 25 mcg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	labetalol HCl, 5 mg per mL, 20 mg per total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 0.5%, 5 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	remifentanil HCl, 50 mcg per mL, 100 mcg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 1%, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	methadone HCl, 10 mg per mL Total Volume in a syringe recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	HYDROmorphone HCl, 0.5 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 2%, Preservative Free, Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 1%, 30 mg per Total Volume in a syringe recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 2%, 40 mg per Total Volume in a syringe recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate Injection, 50 mcg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate Injection, 50 mcg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	PHENYLephrine HCl, 100 mcg per mL, 0.5 mg recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	atropine Sulfate Injection, 0.4 mg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ketamine HCl Injection, 50 mg per mL Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	PHENYLephrine HCl, 100 mcg per mL, 0.5 mg recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ketamine HCl Injection, 50 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 1%, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl, 2%, 20 mg per mL (60 mg per Total Volume in a syringe recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	Heparin Sodium Inj recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 10 mcg per mL (25 mcg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	Heparin Sodium Inj., USP, 5,000 USP Heparin Units per Total recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 5 mcg per mL (10 mcg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	neostigmine Methylsulfate, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	Heparin Sodium Inj recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl 2%, Preservative Free, 20 mg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	midazolam HCl, 1 mg per mL (3 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	neostigmine Methylsulfate, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ePHEDrine Sulfate, 10 mg per mL, 50 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	lidocaine HCl 1%, 10 mg per mL (50 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4% Total recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS I	fentaNYL Citrate, 10 mcg per, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate Injection, 50 mcg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	glycopyrrolate, 0.2 mg per mL, 1 mg per Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	methadone HCl, 2.5 mg per, in 0.9% Sodium Chloride Total recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ketamine HCl, 10 mg per mL, 50 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	glycopyrrolate, 0.2 mg per mL, 0.4 mg per Total Volume recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	PHENYLephrine HCl, 40 mcg per mL, 200 mcg recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ketamine HCl, 10 mg per mL, 20 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	atropine Sulfate Injection, 0.4 mg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	morphine Sulfate, 1 mg per mL (5 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	methadone HCl, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate, 5 mcg per mL (10 mcg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016	CLASS II	fentaNYL Citrate Injection, 50 mcg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide

More recalls from Pharmedium Services

All 291

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020Drug	CLASS II	rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide

Other Fentanyl Per Ml recalls

All 5

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate Injection 50 mcg per mL recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 50 mcg per mL recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide