FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
FDA is recalling compounded Papaverine-Phentolamine-PGE1 injectable vials from Professional Compounding Pharmacy 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves insanitary conditions during the compounding of sterile drugs, which poses a risk of harm without reported illnesses, fitting the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of compounded Papaverine-Phentolamine-PGE1 30-1 mg-20 mcg/ml injectable, 5 ml vials. The product was compounded by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy, located in Corvallis, Oregon.
The recall was initiated because of a lack of processing controls and insanitary conditions observed during the compounding of sterile drugs during a recent FDA inspection. The affected lots are 20092018@41, 25092018@7, and 27092018@3, which were distributed between September 1, 2018, and February 20, 2019. The products were dispensed in Oregon.
Patients who have received these specific vials should contact their healthcare provider or pharmacist for guidance on whether to discontinue use and how to obtain a replacement. Consumers should not use the recalled product until further notice.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, 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:20092018@41
- 25092018@7
- 27092018@3
- 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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