FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
Professional Compounding Pharmacy is recalling specific lots of compounded Papaverine-Phentolamine-PGE1 injectable because FDA inspectors observed insanitary conditions during the compounding process.
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 agency classification is FDA Class II, and the source explicitly cites 'insanitary conditions' during the compounding of sterile drugs, which aligns with the rubric criteria for Severe severity involving significant risk factors.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling two prescription 5ml vials of Papaverine-Phentolamine-PGE1 17.16-0.57mg-19.45mcg/ml injectable. The affected product was dispensed in Oregon between September 1, 2018, and February 20, 2019. The specific lots involved are 30102018@22 and 15112018@5.
The recall was initiated because FDA inspectors observed insanitary conditions during the compounding of sterile drugs during a recent inspection. This lack of processing controls poses a risk to patient safety.
Patients who received this medication should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Category
- Drug — Compounded 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 (3)
- Lot 30102018@22
- 15112018@5
- 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.
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