Professional Compounding Pharmacy Recalls Papaverine-Phentolamine Injectable Due to Insanitary Conditions
Health Solutions Pharmacy Center Inc is recalling Papaverine-Phentolamine 30-0.5 mg/ml injectable due to insanitary conditions observed during compounding.
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, which corresponds to a Severe severity score according to the rubric, particularly given the risk of infection from sterile drug compounding errors.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling Papaverine-Phentolamine 30-0.5 mg/ml injectable, 9ml vials. The recall was initiated because insanitary conditions were observed during the compounding of sterile drugs during a recent FDA inspection.
The affected product was dispensed in Oregon. The specific lot number is 19022019@21, and the product was distributed between September 1, 2018, and February 20, 2019.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE 30-0.5 MG/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:19022019@21
- 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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