Agency classClass IIOur severity:Severe FDA (Drugs)·D-408-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Chloride Injection Due to Sterility Concerns

Green Valley Drugs is recalling 318 vials of Sodium Chloride Injection due to a 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 FDA classified this recall as Class II, and the hazard involves a lack of sterility assurance for injectable products, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 318 vials of Sodium Chloride Injection, including Bacteriostatic Sodium Chloride 0.9% 30 mL, Sodium Chloride 23.4% 30 mL PF, and Sodium Chloride 23.4% 50 mL. The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy, as well as concerns associated with its quality control processes.

The affected products are prescription-only and were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation. The FDA has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, 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: 318

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 (7)

Lot #: a) Bacteriostatic Sodium Chloride 0.9% 30 mL
20121205
Exp 6/11/2013
b) Sodium Chloride 23.4% 30 mL PF: 20130115-G
Exp 4/15/2013
c) Sodium Chloride 23.4% 50 mL: 20130114-E
Exp 4/14/2013

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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