Agency classClass IIOur severity:Severe FDA (Drugs)·D-404-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Chloride and Dexamethasone Injection

Green Valley Drugs is recalling 950 syringes of Sodium Chloride and Dexamethasone Injection due to lack of assurance of sterility and quality control concerns.

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, and the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 950 syringes of Sodium Chloride and Dexamethasone Injection, all strengths and presentations. The affected products include SOD_CHLOR-DEXAMETH-0.9-10-3 and SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, which are prescription-only items distributed nationwide.

The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the facility's quality control processes as the reason for the action.

Consumers and healthcare providers should stop using the affected products immediately. Specific lot numbers and expiration dates are listed in the official recall notice. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product: Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer: FVS Holdings, Inc. dba. Green Valley Drugs
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 950

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 (20)

Lot #: a) SOD_CHLOR-DEXAMETH-0.9-10-3: 13011450GV3
Exp 4/14/2013
13011450GV2
13011760A
Exp 4/17/2013
13012440
Exp 4/24/2013
13020425GV2
Exp 5/4/2013
2013021950GV1
Exp 5/19/2013
b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3: 13031330GV1
Exp 6/13/2013
13031460GV1
Exp 6/14/2013
13032740GV2
Exp 6/27/2013
20130327GV1
13021920GV1
130301100GV3

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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