Agency classClass IIOur severity:High FDA (Drugs)·D-0035-2023·Announced 2022-11-09

Lidocaine/Phenylephrine Injectable Solution Recalled for Sterility Defect

Pharmacy Plus Inc.'s Lidocaine/Phenylephrine injectable solution is recalled due to manufacturing process deficiencies that cannot guarantee product sterility. The recall affects 389 syringes 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 of an injectable medication with manufacturing deficiencies preventing sterility assurance. No illnesses, injuries, or deaths reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity rating.

Plain-English summary

Pharmacy Plus, Inc. (doing business as Vital Care Compounder) is recalling Lidocaine/Phenylephrine PF Solution 1%/1.5% in 3 mL syringes. The affected lot is 65972, with a Beyond Use Date of October 27, 2022, and 389 syringes are involved.

The recall is due to a lack of assurance of sterility. During FDA inspection, the agency determined that the recalled products were produced in a manner that cannot guarantee the sterility required for injectable products.

The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. This recall affects any remaining product from the specified lot that may be in use or in inventory.

Patients and healthcare providers who have this product should be aware of the recall. Contact with a healthcare provider may be appropriate for those who have received doses from this affected lot.

The recalled product

Product: LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Manufacturer: Pharmacy Plus, Inc. dba Vital Care Compounder
Category: Drug — Compounded Injectable
Hazard: sterility-defect
contamination-risk
Affected units: 389

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: 65972
BUD: 10/27/2022

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 defect