Agency classClass IIOur severity:High FDA (Drugs)·D-0034-2023·Announced 2022-11-09

Laureth-9 Injectable Solution Recalled for Lack of Sterility Assurance

A compounded Laureth-9 injectable solution has been recalled after the FDA found the manufacturing process could not guarantee sterility. The recalled product (lot 66513) was distributed in 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 for lack of sterility assurance in a compounded injectable. No illnesses have been reported, but loss of sterility in products intended for injection poses significant infection risk due to direct entry into the body.

Plain-English summary

Pharmacy Plus, Inc., operating as Vital Care Compounder, is recalling Laureth-9 INJ 2% Solution in 30 mL vials. The recalled product is lot 66513 with a beyond-use date of 11/10/2022. It was manufactured at 115 S. 40th Ave., Hattiesburg, MS 39402.

The FDA conducted an inspection and determined that the recalled products were manufactured in a manner that cannot guarantee the sterility of these products. Sterility is essential for injectable medications, as injectables bypass the body's natural protective barriers.

The recalled vials were distributed to pharmacies in Alabama, Louisiana, Mississippi, and Tennessee.

Patients who have received this product should consult their prescribing healthcare provider. Healthcare providers and pharmacies should discontinue dispensing this lot and segregate any remaining inventory.

The recalled product

Product: LAURETH-9 INJ 2% Solution, 30 ML vial, 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-failure
contamination-risk
Affected units: 3

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: 66513
BUD: 11/10/2022

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 failure