FDA Recalls Compounded Papaverine-Phentolamine Injectable Due to Insanitary Conditions
FDA is recalling compounded papaverine-phentolamine injectable due to insanitary conditions observed during compounding of sterile drugs.
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. Per the rubric, FDA Class II recalls with potential for adverse health consequences are classified as Severe (Score 4), particularly given the risk associated with sterile drug compounding errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling compounded papaverine-phentolamine 30-1 mg/ml injectable, a penile injection product. The recall is being conducted by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy in Corvallis, Oregon.
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 was dispensed in Oregon 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 FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, 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:(a) 08102018@11
- 27122018@33
- (b) 30012019@43
- 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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