Agency classClass IIOur severity:High FDA (Drugs)·D-0050-2023·Announced 2022-11-09

Phentolamine Injectable Drug Recalled Due to Sterility Concerns

Pharmacy Plus recalls Phentolamine 10MG/ML injection due to lack of guaranteed sterility during production. Affected lots 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: FDA Class II recall for a sterile injectable drug with lack of assurance of sterility represents a risk-of-harm product where no illnesses or injuries have been reported. The absence of reported illnesses combined with a theoretical hazard meets the rubric criterion for High severity.

Plain-English summary

Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Phentolamine 10MG/ML injection supplied in 10 mL vials. The recall affects lots 60586 (BUD 11/01/2022) and 64203 (BUD 01/28/2023), which were distributed in Alabama, Louisiana, Mississippi, and Tennessee.

The U.S. Food and Drug Administration (FDA) conducted an inspection and determined that the recalled products were produced in a manner that cannot guarantee the sterility of products purported to be sterile. Phentolamine is a prescription injectable medication used for intravenous or intramuscular administration.

Healthcare providers and patients in the affected states who have received this medication should consult with their pharmacist or healthcare provider immediately. Do not use the recalled lots. Return the product to the dispensing pharmacy or contact Pharmacy Plus for guidance on disposal or replacement options.

The recalled product

Product: PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Manufacturer: Pharmacy Plus, Inc. dba Vital Care Compounder
Category: Drug — Injectable / Sterile Product
Hazard: lack-of-sterility
infection-risk
Affected units: 10

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 (4)

Lots: 60586
BUD: 11/01/2022
64203
BUD: 01/28/2023

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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