FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant risks or specific agency classifications are assigned a severity score of 4 (Severe), particularly when structural or process failures like 'insanitary conditions' in sterile compounding are involved.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. The recall is classified as Class II.
The recall was initiated because of a lack of processing controls, specifically insanitary conditions observed during the compounding of sterile drugs during a recent FDA inspection. The affected product is a prescription injectable solution.
The recalled product was dispensed in Oregon. The specific lot number is 17012019@27, and it was distributed between September 1, 2018, and February 20, 2019. Patients who have received this medication should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
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:17012019@27
- 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 →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02