CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report

Papaverine-phentolamine-PGE1 17.44-0.64MG-5.8MCG/ML* recalled

Health Solutions Pharmacy Center is recalling Papaverine-phentolamine-PGE1 17.44-0.64MG-5.8MCG/ML* Injectable, Professional Compounding, distributed in Oregon. The recall was initiated on 21 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot:13092018@44, distributed between 09-01-2018 to 02-20-2019.
Quantity recalled1 prescription, 5ml injection

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-1110-2019
FDA event ID
82278
Recalling firm
Health Solutions Pharmacy Center, Corvallis, OR
Classification
Class II
Status
Terminated
Recall initiated
21 Feb 2019
FDA classified
9 Apr 2019
Reported
17 Apr 2019
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

21 Feb 2019Recall initiated by company
9 Apr 2019Classified by FDA+47 days
17 Apr 2019Published 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

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during 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-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Where it was distributed

Dispensed in Oregon

Oregon

Questions about this recall

Why was it recalled?

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Which lots are affected?

Lot:13092018@44, distributed between 09-01-2018 to 02-20-2019.

Where was it sold?

Dispensed in Oregon

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

24 other products · FDA event 82278
ReportedClassRecallCompanyReasonWhere
CLASS IIPapaverine-phentolamine 15-0.5MGMG/ML Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 16.6-0.55 Mg-11.1 Mcg/ML* recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 23-0.96MG-19.2MCG/ML recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPGE1 40 MCG/ML* Injectable (b), (c) (d) recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 17.64-0.58MG-5.88MCG/ML* recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 12-1MG-10MCG/ML Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPGE1-Lidocaine 40 Mcg-1% /ML* Injectable, (a) (b) recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 15-0.25MG-6MCG/ML Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIAcetyl-l-cysteine 10% P.F. Ophth Solution, eye drops recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIDexamethasone (NAPO4) 0.1% Ophth* Pres-free Solution recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 22.5-0.8MG-8.3MCG/ML recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 15-0.5MG-10MCG/ML Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IISodium Chloride Pres-free 5% Ophth Sterile* Solution recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 9-1 Mg-10 Mcg/ML* Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 30-1.6 Mg-16 Mcg/ML* recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 30-1 Mg-10 Mcg/ML* Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 17.44-0.58MG-5.8MCG/ML* recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine 30-1 MG/ML* Injectable, (a) (b) recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIHydroxyprogesterone Caproate 250 MG/ML Oil* Injectable, (a) recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 22-0.8 Mg-8 Mcg/ML* Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 30-2 Mg-30 Mcg/ML* Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine 30-0.5 MG/ML Injectable recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 17.16-0.57MG-19.45MCG/ML* recalledHealth Solutions Pharmacy CenterSterilityOR
CLASS IIPapaverine-phentolamine-PGE1 30-1 Mg-20 Mcg/ML* Injectable recalledHealth Solutions Pharmacy CenterSterilityOR

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