FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
The FDA is recalling compounded Papaverine-Phentolamine-PGE1 injectable products from Professional Compounding Pharmacy in Oregon 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when involving sterile drug compounding issues that imply significant risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of compounded Papaverine-Phentolamine-PGE1 injectable products manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy in Corvallis, Oregon. The recall involves 13 prescription vials in 5ml, 6ml, 9ml, and 10ml sizes. These products were dispensed in Oregon between September 1, 2018, and February 20, 2019.
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 agency has classified this as a Class II recall.
Patients who have received these specific compounded injectable products should contact their healthcare provider or the pharmacy for further instructions on how to proceed. The recall is limited to the specific lot numbers and distribution dates listed in the official FDA notice.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, 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 (14)
- Lot: (a) 03102018@27
- 07112018@18
- 08112018@11
- 16112018@15
- 28112018@7
- 14122018@37
- 16112018@41
- 03012019@9
- (b) 2012019@32
- 23012019@59
- (c)07022019@19
- 07022019@1
- (d)19122018@25
- 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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