Compounded Injectable Drug Recalled Due to Sterility Assurance Defect
A compounded injectable medication containing papaverine, phentolamine, and prostaglandin was recalled after FDA inspection found it was not produced under conditions that guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a compounded sterile injectable drug with a manufacturing defect affecting sterility assurance. No illnesses or injuries have been reported. The recalled product poses a risk of harm from potential contamination, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Vital Care Compounder of Hattiesburg, Mississippi is recalling a compounded injectable medication containing papaverine, phentolamine, and prostaglandin. The product is provided in 5 mL vials and is prescription-only.
The FDA inspection found that the recalled product was manufactured in a manner that cannot guarantee the sterility of the medication. This product is intended to be sterile.
The recalled product (Lot 65425, beyond-use date October 13, 2022) was distributed in Alabama, Louisiana, Mississippi, and Tennessee. Patients and healthcare providers with this product should contact their healthcare provider for guidance.
The recalled product
- Product
- PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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: 65425
- BUD: 10/13/2022
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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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