FDA Recalls Papaverine-Phentolamine Injectable Due to Insanitary Compounding Conditions
Professional Compounding Pharmacy is recalling Papaverine-Phentolamine 15-0.5mg/mL injectable vials because FDA inspectors observed insanitary conditions during the 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination scenarios.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling specific vials of Papaverine-Phentolamine 15-0.5mg/mL Injectable. The product is a 9ml sterile injectable solution.
The recall was initiated because FDA inspectors observed insanitary conditions during the compounding of sterile drugs during a recent inspection. This lack of processing controls poses a risk to the sterility and safety of the medication.
The affected product was dispensed in Oregon. The specific lot number is 15012019@10, and it was distributed between September 1, 2018, and February 20, 2019. Patients who have received this medication should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, 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 (2)
- Lot:15012019@10
- 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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