FDA Recalls Compounded Papaverine Injectable Due to Insanitary Conditions
Professional Compounding Pharmacy is recalling compounded papaverine-phentolamine-PGE1 injectable due to insanitary conditions observed during an FDA inspection.
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, and the rubric specifies that FDA Class II recalls involving significant risks or specific conditions like insanitary compounding of sterile drugs fall under the Severe category.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. The recall is classified as Class II.
The recall was initiated because insanitary conditions were observed during the compounding of sterile drugs during a recent FDA inspection. This lack of processing controls poses a risk to the sterility and safety of the medication.
The affected product, Lot 19092018@1, was distributed between September 1, 2018, and February 20, 2019. The medication was dispensed in Oregon. Patients who have received this prescription should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/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 (2)
- Lot:19092018@1
- 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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