Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Vital Care Compounder is recalling an injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found production methods cannot guarantee product sterility. The recalled lot 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: FDA Class II recall for an injectable medication where manufacturing processes cannot assure sterility. Although no illnesses or injuries have been reported, the inability to guarantee sterility in injectable products represents a risk-of-harm scenario where infection could result.
Plain-English summary
Vital Care Compounder, located in Hattiesburg, Mississippi, is recalling one lot of a compounded injectable medication containing Papaverine, Phentolamine, and Prostaglandin (150/5/50 mcg per 10 mL vial). This is a prescription-only medication prepared by a pharmacy compounding facility.
The FDA inspection identified that the products were produced using processes that do not guarantee sterility. For injectable medications intended to be sterile, the inability to ensure sterility represents a significant safety concern, as non-sterile injections can introduce infections.
This recall affects Lot 65594 with a beyond-use date of 10/16/2022, which was distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee. If you or someone in your care received this medication, contact your healthcare provider or pharmacy immediately. Do not use remaining doses without consulting your healthcare provider.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Hazard
- Affected units
- 5
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: 65594
- BUD: 10/16/2022
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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