Agency classClass IIOur severity:Severe FDA (Drugs)·D-361-2013·Announced 2013-05-22

Green Valley Drugs Recalls Edetate Disodium Injection Due to Sterility Concerns

Green Valley Drugs is recalling Edetate Disodium 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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks like sterility assurance failures in injectable drugs.

Plain-English summary

Green Valley Drugs, a compounding pharmacy located in Henderson, Nevada, is recalling Edetate Disodium Injection in all strengths and presentations. The recall includes specific vials of Edetate Disodium 150/30 mL and Edetate Disodium 150/100 mL. The affected products were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The company identified concerns associated with its quality control processes regarding all sterile products that were compounded, repackaged, and distributed by the pharmacy. The FDA has classified this recall as Class II.

Patients who have received these injections should consult their healthcare providers. The source text does not specify a particular number of affected units or report any illnesses or injuries associated with the use of these products.

The recalled product

Product: Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 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-failure
infection-risk
Affected units: 98

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 (9)

Lot #: a) Edetate Disodium_150/30 mL: 20130201-E
Exp 5/2/2013
b) Edetate Disodium_150/100 mL: 20130124-B
4/24/2013
20130213-B
Exp 5/13/2013
20130213-C
20130401-B
Exp 7/1/2013

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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Same hazard · sterility failure