FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
Health Solutions Pharmacy Center is recalling compounded papaverine-phenolamine-PGE1 injectable vials because FDA inspectors observed insanitary conditions during the compounding process.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural or process defects in sterile drug compounding.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling specific lots of Papaverine-Phentolamine-PGE1 22.5-0.8mg-8.3mcg/ml Injectable, 5 ml. The recall was initiated after the U.S. Food and Drug Administration (FDA) observed insanitary conditions during the compounding of sterile drugs during a recent inspection.
The affected product was dispensed in Oregon between September 1, 2018, and February 20, 2019. The recall involves two prescriptions of 5 ml injections. The specific lot numbers are 26112018@68 and 13122018@12.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall 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 22.5-0.8MG-8.3MCG/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 (3)
- Lot:26112018@68
- 13122018@12
- 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.
See all 25 products in this recall →Related recalls
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