FDA Recalls Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Compounding Conditions
FDA is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable 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 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; however, since no injuries are reported, it falls under the general Class II category which is typically Severe or High. Given the 'insanitary conditions' in sterile compounding, it is treated as Severe (4) due to the potential for serious harm from contamination, though no specific injuries are cited in the text, the Class II designation for sterile drugs often warrants a higher severity due to the nature of the hazard.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of Papaverine-Phentolamine-PGE1 23-0.96mg-19.2mcg/ml Injectable. The product was compounded 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 lots are (a) 22102018@31 and (b) 09112018@33, which were distributed between September 1, 2018, and February 20, 2019.
The product was dispensed in Oregon. Consumers who have this medication should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Category
- Drug — 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: (a) 22102018@31
- (b) 09112018@33
- 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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