Agency classClass IIOur severity:High FDA (Drugs)·D-0046-2023·Announced 2022-11-09

Injectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure

Pharmacy Plus, Inc. is recalling 242 vials of papaverine/phentolamine injection because FDA inspection found the products were produced in conditions that cannot guarantee sterility. The affected lots were distributed to AL, LA, MS, and TN.

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 involving a high-risk injectable medication with documented sterility assurance failures, presenting a significant risk of microbial contamination and infection. No illnesses or injuries have been reported to date, limiting the score to 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 242 vials of Papaverine/Phentolamine Injection (150mg/5mg per 10 mL vial). The affected lots are: 55092 (BUD 10/22/2022), 59100 (BUD 10/30/2022), 62038 (BUD 04/08/2023), and 66533 (BUD 04/08/2023).

The recall was initiated after an FDA inspection found that these products were manufactured in a manner that cannot guarantee their sterility. Sterile injectable medications must be produced under strict conditions to prevent bacterial, fungal, or other microbial contamination.

The affected products were distributed to healthcare facilities and pharmacies in Alabama, Louisiana, Mississippi, and Tennessee.

Patients who have received this medication or healthcare providers who have doses of these lots should contact Pharmacy Plus, Inc. or consult their healthcare provider. Do not use any remaining product from the affected lots.

The recalled product

Product: PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / 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
Category: Drug — Injectable Solution
Hazard: sterility-failure
contamination
Affected units: 242

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 (7)

Lots: 55092
BUD: 10/22/2022
59100
BUD: 10/30/2022
62038
BUD: 04/08/2023
66533

Distribution

Distributed in 4 states:

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.

See all 32 products in this recall →

Same manufacturer · Pharmacy Plus, Inc. dba Vital Care Compounder

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Same hazard · sterility failure