FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
Health Solutions Pharmacy Center is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.
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 source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant process failures like insanitary conditions in sterile compounding.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for a compounded sterile drug product. The affected product is PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML INJECTABLE, 5ml, manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy 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 specific lot number is 15112018@40, which was distributed between September 1, 2018, and February 20, 2019. The product was dispensed in Oregon.
Consumers who have this specific product should contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication. This recall is classified 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 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
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 (2)
- Lot:15112018@40
- 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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