FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions
Professional Compounding Pharmacy is recalling a compounded injectable drug because FDA inspectors observed insanitary conditions during its 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 recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a sterile injectable drug with observed insanitary conditions (a significant risk of contamination) aligns with the 'Severe' criteria, as it presents a significant risk of harm even without reported hospitalizations.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for a compounded injectable drug containing papaverine, phentolamine, and PGE1. The product is an 18 ml injection manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy in Corvallis, Oregon.
The recall was initiated because FDA inspectors observed insanitary conditions during the compounding of sterile drugs during a recent inspection. This lack of processing controls poses a risk of contamination to the sterile product.
The affected product was dispensed in Oregon. The specific lot number is 12022019@23, and it was distributed between September 1, 2018, and February 20, 2019. Consumers who have this product should contact their healthcare provider or the pharmacy for instructions on how to dispose of or return the medication.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 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:12022019@23
- 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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