Agency classClass IIOur severity:Severe FDA (Drugs)·D-405-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Bicarbonate and Lidocaine Injection

Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection due to a lack of assurance of sterility in its compounding and quality control processes.

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 involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection, all strengths and presentations. The recall was initiated because the compounding pharmacy lacked assurance of sterility for all sterile products it compounded, repackaged, and distributed, raising concerns about its quality control processes.

The affected product is distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between April and June 2013.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product: Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, 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-failure
infection
Affected units: 335

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 (14)

Lot #: 20130226-GV4
Exp 5/26/2013
13031150GV3
Exp 6/11/2013
13031240GV4
Exp 6/12/2013
13012325GV5
Exp 4/23/2013
13021820GV3
Exp 5/18/2013
13011520
Exp 4/15/2013
13012425GV1
Exp 4/24/2013

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