CLASS II Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report

Oxytocin added to Lactated Ringers in a lntravia recalled

Pharmakon Pharmaceuticals is recalling Oxytocin added to Lactated Ringers in a lntravia, distributed nationwide in the US. The recall was initiated on 20 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Sterile Compounded Products within Expiry

Quantity recalled72

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-1297-2016
FDA event ID: 73960
Recalling firm: Pharmakon Pharmaceuticals, Noblesville, IN
Classification: Class II
Status: Terminated
Recall initiated: 20 Apr 2016
FDA classified: 11 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

20 Apr 2016	Recall initiated by company
11 Jul 2016	Classified by FDA	+82 days
20 Jul 2016	Published in enforcement report	+9 days

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

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03

Where it was distributed

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Nationwide California Kentucky Maryland North Carolina Oklahoma Texas Virginia

Questions about this recall

Is Oxytocin added to Lactated Ringers in a lntravia recalled?

Yes. Pharmakon Pharmaceuticals recalled Oxytocin added to Lactated Ringers in a lntravia on 20 Apr 2016. The recall is Class II and its status is Terminated. Recall number D-1297-2016.

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All Sterile Compounded Products within Expiry

Where was it sold?

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Pharmakon Pharmaceuticals

All 116

Reported	Class	Recall	Company	Reason	Where
20 Jul 2016Drug	CLASS II	Succinylcholine Chloride 20 mg/mL BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Ketamine 20 mg/mL in 9% Sodium Chloride lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	HYDROmorphone HCI 2 mg/mL in 9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Ketamine 50mg/mL in 9% Sodium Chloride fill in syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Cefazolin 2GM added to 5% Dextrose recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide