CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Papaverine-phentolamine 15-0.5MGMG/ML Injectable recalled
Health Solutions Pharmacy Center is recalling Papaverine-phentolamine 15-0.5MGMG/ML Injectable, Professional Compounding Pharmacy, 996, distributed in Oregon. The recall was initiated on 21 Feb 2019 and the FDA has classified it as Class II.
Check your package
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-1099-2019
- 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
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Feb 2019 | Recall initiated by company | |
| 9 Apr 2019 | Classified by FDA | +47 days |
| 17 Apr 2019 | 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
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 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Where it was distributed
Dispensed in 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:15012019@10, 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 82278This product is part of a recall event; the main page for the event is Papaverine-phentolamine-PGE1 17.44-0.64MG-5.8MCG/ML* recalled.