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.
What this means for you
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
- 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
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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