The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-407-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 6,213 vials of Sodium Bicarbonate Injection due to a lack of assurance of sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile injection) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 6,213 vials of Sodium Bicarbonate Injection in all strengths and presentations. The affected products include Sodium Bicarb 4.2% 5 mL PF, Sodium Bicarb 8.4% 50 mL SDV, and Sodium Bicarbonate 8.4% Rx only. The recall is being conducted due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy, stemming from concerns associated with its quality control processes.

The affected products were distributed nationwide. Specific lot numbers and expiration dates are listed in the official recall documentation. No illnesses or injuries have been reported in the source text.

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

The recalled product

Product
Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
6,213

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 #: Sodium Bicarb 4.2% 5 mL PF: 130123150AE
  • Exp 4/23/2013
  • b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L
  • Exp 6/15/2013
  • c) Sodium Bicarbonate 8.4%: 20130117-D
  • Exp 4/17/2013
  • 20130117-E
  • 20130117-F
  • 20130121-B
  • Exp 4/21/2013
  • 20130121-C
  • 20130121-D
  • 20130121-E
  • 20130121-F
  • 20130121-H
  • 20130121-I
  • 20130121-J
  • 20130121-K
  • Exp 4/21/2013
  • 20130124-D

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 →

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