Professional Compounding Pharmacy Recalls Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
Professional Compounding Pharmacy is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as those involving sterile compounding errors) are categorized as Severe.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling specific lots of Papaverine-Phentolamine-PGE1 12-1mg-10mcg/ml Injectable. The recall involves 10ml and 9ml vials distributed in Oregon between September 1, 2018, and February 20, 2019.
The recall was initiated due to a lack of processing controls. During a recent FDA inspection, inspectors observed insanitary conditions during the compounding of sterile drugs. This classification indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
Patients who received these specific prescriptions should contact their healthcare provider or the pharmacy for guidance on what to do with the medication. The affected lots are identified by specific dates and quantities listed in the recall documentation.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, 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 (10)
- Lot (a)17102018@15
- 14112018@3
- 04122018@21
- 14122018@15
- 7122018@11
- 28122018@69
- 20092018@2
- (b) 21012019@37
- 22012019@31
- 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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