Agency classClass IIOur severity:Severe FDA (Drugs)·D-369-2013·Announced 2013-05-22

Green Valley Drugs Recalls Glycerin/Lidocaine/Epinephrine Injection Due to Sterility Concerns

Green Valley Drugs is recalling Glycerin/Lidocaine/Epinephrine Injection because the pharmacy could not ensure the sterility of the compounded products.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Under the severity rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in injectable drugs is categorized as Severe.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Glycerin/Lidocaine/Epinephrine Injection, including Glycerin 72% Lido:Epi 2-1-30 mL, which is prescription-only. The product was compounded, repackaged, and distributed by the pharmacy.

The recall is being conducted due to a lack of assurance of sterility for all sterile products handled by the facility. The FDA identified concerns associated with the pharmacy's quality control processes that prevented them from guaranteeing the sterility of the products.

The affected lot number is 20130211-U, with an expiration date of 5/11/2013. The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer: FVS Holdings, Inc. dba. Green Valley Drugs
Category: Drug — Compounded Injectable
Hazard: sterility
infection

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 #: 20130211-U
Exp 5/11/2013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs 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 78 products in this recall →

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

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