FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
Health Solutions Pharmacy Center is recalling compounded Papaverine-Phentolamine-PGE1 injectables because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile drug compounding failures that pose significant health risks.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Papaverine-Phentolamine-PGE1 30-1.6 mg-16 mcg/ml Injectable, 5ml and 10ml vials. The product was compounded by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy in Corvallis, Oregon.
The recall was initiated due to a lack of processing controls. During a recent FDA inspection, inspectors observed insanitary conditions during the compounding of sterile drugs. The affected lots were distributed in Oregon between September 1, 2018, and February 20, 2019.
Patients who have received this medication should contact their healthcare provider for guidance on alternative treatment options. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, 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 (4)
- Lot: 05102018@36
- 27112018@49
- (b) 28112018@54
- 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
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