Professional Compounding Pharmacy Recalls Papaverine-Phentolamine Injectable Due to Insanitary Conditions
Health Solutions Pharmacy Center Inc is recalling Papaverine-Phentolamine 30-0.5 mg/ml injectable due to insanitary conditions observed during compounding.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric, particularly given the risk of infection from sterile drug compounding errors.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling Papaverine-Phentolamine 30-0.5 mg/ml injectable, 9ml vials. The recall was initiated because insanitary conditions were observed during the compounding of sterile drugs during a recent FDA inspection.
The affected product was dispensed in Oregon. The specific lot number is 19022019@21, and the product was distributed between September 1, 2018, and February 20, 2019.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot:19022019@21
- distributed between 09-01-2018 to 02-20-2019.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 25 recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 25 products in this recall →Related recalls
Same manufacturer · Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
See all →- SevereFDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions
FDA (Drugs) · 2019-04-17
- SevereFDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
FDA (Drugs) · 2019-04-17
- SevereFDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions
FDA (Drugs) · 2019-04-17
- Severe
- Severe
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighFDA Recalls Papaverine/Phentolamine Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2023-02-01
- SevereFDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereKey Pharmacy Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns
FDA (Drugs) · 2017-05-24
- SevereKey Pharmacy Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns
FDA (Drugs) · 2017-05-24
- SevereFDA Recalls Compounded Injectable Drug Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Papaverine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12