CLASS I Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report

oxyTOCIN added to 5% Dextrose Injection recalled by Pharmedium Services

Pharmedium Services is recalling oxyTOCIN added to 5% Dextrose Injection USP, distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 15041113S, Exp 04/23/15

Quantity recalled72 bags

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-1353-2015
FDA event ID: 71846
Recalling firm: Pharmedium Services, Lake Forest, IL
Classification: Class I
Status: Terminated
Recall initiated: 13 Apr 2015
FDA classified: 25 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

13 Apr 2015	Recall initiated by company
25 Aug 2015	Classified by FDA	+134 days
2 Sep 2015	Published in enforcement report	+8 days

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

Reason for recall

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Product as listed by the FDA

oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: 15041113S, Exp 04/23/15

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

5 other products · FDA event 71846

This product is part of a recall event; the main page for the event is Heparin Sodium Injection recalled by Pharmedium Services.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2015	CLASS I	Heparin Sodium Injection recalled by Pharmedium Services	Pharmedium Services	Particulate Matter	Nationwide
2 Sep 2015	CLASS I	EPINEPHrine HCl 4 mg added to 0.9% Sodium Chloride recalled	Pharmedium Services	Particulate Matter	Nationwide
2 Sep 2015	CLASS I	EPINEPHrine HCl 16 mg added to 0.9% Sodium Chloride recalled	Pharmedium Services	Particulate Matter	Nationwide
2 Sep 2015	CLASS I	EPINEPHrine HCl 1 mg added to 0.9% Sodium Chloride recalled	Pharmedium Services	Particulate Matter	Nationwide
2 Sep 2015	CLASS I	Heparin Sodium Injection USP 25,000 USP Units added recalled	Pharmedium Services	Particulate Matter	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 Oxytocin Added To Dextrose recalls

All 3

Reported	Class	Recall	Company	Reason	Where
1 Nov 2017Drug	CLASS II	Oxytocin added to 5% Dextrose/Lactated Ringer's recalled	Pharmedium Services	Potency & Assay	Nationwide
1 Nov 2017Drug	CLASS II	Oxytocin added to 5% Dextrose/Lactated Ringer's recalled	Pharmedium Services	Potency & Assay	Nationwide