Pharmacy Compounded Injection Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling a compounded injectable medication because manufacturing did not ensure 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 is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential contamination from non-sterile manufacturing—rather than realized harm. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling a compounded injectable solution containing papaverine (150 mg), phentolamine (10 mg), and prostaglandin (100 mcg) in 5 mL vials. The recalled lot is 66576, with a beyond-use date of November 9, 2022.
An FDA inspection found that the product was manufactured in a manner that cannot guarantee its sterility. The solution was purported to be sterile but failed to meet the manufacturing standards necessary to ensure sterility.
The recalled medication was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Patients and healthcare providers who may have received this lot should not use it. Anyone with questions about whether they received the recalled product should contact their pharmacist or healthcare provider.
The recalled product
- Product
- PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ 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: 66576
- BUD: 11/09/2022
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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