CLASS II Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report

Papaverine HCL/Phentolamine Mes/Prostaglandin, 23mg/0 recalled

Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine Mes/Prostaglandin, 23mg/0, distributed in Oregon, Washington. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 20140708@30, discard date: 12/2/2014

Quantity recalled46.7 mL

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-0213-2015
FDA event ID: 69519
Recalling firm: Oregon Compounding Centers, Wilsonville, OR
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2014
FDA classified: 31 Oct 2014
Reported: 12 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

6 Oct 2014	Recall initiated by company
31 Oct 2014	Classified by FDA	+25 days
12 Nov 2014	Published in enforcement report	+12 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 Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

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

PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

Where it was distributed

Oregon, Washington

Oregon Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: 20140708@30, discard date: 12/2/2014

Where was it sold?

Oregon, Washington

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

55 other products · FDA event 69519

This product is part of a recall event; the main page for the event is Hydroxyprogesterone Caproate (Sesame Oil), 250mg/mL recalled.

Reported	Class	Recall	Company	Reason	Where
12 Nov 2014	CLASS II	Hydroxyprogesterone Caproate (Sesame Oil), 250mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Ceftazidime, 2.25mg/, Injectable plastic syringe, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine/Phentolamine/Prostaglandin recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Epinephrine/Water, preservative free 1:1000 recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Procaine HCL (Buff), 1%, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Methycobalamin, preservative free, 10mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Citric Acid/Gluconolactone Magnes Carb (Renacidin) recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Alprostadil, 10 mcg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Methycobalamin, preservative free, 20mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Testosterone Cypionate (Grape Seed Oil/Compounded) recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Glutathione with preservative, 100mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Glutathione, 100 mg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine HCL/Phentolamine/Prostaglandin recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine HCL, with preservative, 30 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Ganciclovir -preservative free, 2mg recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Bevacizumab/Dexamethasone, Injectable plastic syringe, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Tobramycin, 480mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine/Phentolamine/Prostaglandin recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Hydroxocobalamin-preservative free (B12), 1mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Vitamin B Complex (Pres) injectable, 100mg glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Pyridoxine HCL, with preservative, 100 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Mitomycin, 0.3mg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine/Phentolamine/Alprostadil, 26.5mg/0.98mg/58.9mcg recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Alprostadil/Lidocaine HCL, 20mcg/5mg/mL glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Glutaraldehyde Buffered (Potassium Phosphate), solution recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Hydroxocobalamin- preservative (B12), 1mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Omnipaque, 300mgI/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Prednisolone Sodium Phosphate, 1%, Ophthalmic, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Dexamethasone (AS Sod Phos), 24 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Testosterone Cypionate (Sesame Oil/Cmpd), 200mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Triesence, 8mg/, Injectable plastic syringe, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Ascorbic Acid (B), 500 mg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Ascorbic Acid (with Preservative), 500 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Mitomycin, 0.2mg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Methycobalamin, preservative, 1mg/mL, injectable glass vial recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Ganciclovir, preservative free, 0.2mg recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Lidocaine HCL (Repkg-sterile), 4%, solution for irrigation recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Chorionic Gonadotropin, sterile powder for reconstitution recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Hyaluronidase, 240 u/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Estradiol Cypionate (Compounded/Grapeseed Oil), 5 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Vancomycin, 1mg/, injectable plastic syringe, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Dexpanthenol with preservative, 250 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Gentamicin Sulfate, 480mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Methycobalamin, preservative free, 1mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine/Phentolamine/Prostaglandin recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Copper (Sulf), 0.4 mg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Chorionic Gonadotropin, sterile powder for reconstitution recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Dmps-preservative free, 50 mg/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papav HCL/Phentol/Prostagl, 12mg/1mg/10mcg recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine HCL/Phentolamine Mes/Alprostadil recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Calcium Chloride (Compound), 100 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Gentamicin Sulfate, 100mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Avastin, 1.25mg/, injectable plastic syringe, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Papaverine HCL/Phentolamine/Alprostadil recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014	CLASS II	Sodium Chloride Inhalation, 7%, Solution recalled	Oregon Compounding Centers	Sterility	OR, WA

More recalls from Oregon Compounding Centers

All 56

Reported	Class	Recall	Company	Reason	Where
12 Nov 2014Drug	CLASS II	Sodium Chloride Inhalation, 7%, Solution recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014Drug	CLASS II	Papaverine HCL/Phentolamine/Alprostadil recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014Drug	CLASS II	Avastin, 1.25mg/, injectable plastic syringe, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014Drug	CLASS II	Gentamicin Sulfate, 100mg/, solution for irrigation, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
12 Nov 2014Drug	CLASS II	Calcium Chloride (Compound), 100 mg/mL recalled	Oregon Compounding Centers	Sterility	OR, WA

Other Papaverine recalls

All 64

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS I	Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	American Regent	Particulate Matter	Nationwide
1 Feb 2023Drug	CLASS II	Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled	Pharmacy Innovations	Sterility	Nationwide
9 Nov 2022Drug	CLASS II	Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus	Pharmacy Plus	Sterility	4 states
9 Nov 2022Drug	CLASS II	Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled	Pharmacy Plus	Sterility	4 states
9 Nov 2022Drug	CLASS II	Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled	Pharmacy Plus	Sterility	4 states