FDA Drug recall D-407-2013

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…

FDA Drug
Class II
terminated
Published 2013-05-22

On 2013-05-22 the FDA classified a Class II recall of 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… by Fvs Holdings Dba Green Valley Drugs, citing lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associate….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-407-2013
Classification	Class II
Status	terminated
Initiated	2013-04-10
Published	2013-05-22
Last updated	2026-09-13 11:51 UTC
Company	Fvs Holdings Dba Green Valley Drugs
Distribution	US

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.

Reason

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Identifiers

code_info	Lot #: Sodium Bicarb 4.2% 5 mL PF: 130123150AE, Exp 4/23/2013; b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L, Exp 6/15/20… 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, Exp 4/17/2013; 20130117-F, Exp 4/17/2013; 20130121-B, Exp 4/21/2013; 20130121-C, Exp 4/21/2013; 20130121-D, Exp 4/21/2013; 20130121-E, Exp 4/21/2013; 20130121-F, Exp 4/21/2013; 20130121-H, Exp 4/21/2013; 20130121-I, Exp 4/21/2013; 20130121-J, Exp 4/21/2013; 20130121-K, Exp 4/21/2013; 20130124-D, Exp 4/24/2013; 20130124-E, Exp 4/24/2013; 20130129-B, Exp 4/29/2013; 20130129-C, Exp 4/29/2013; 20130129-D, Exp 4/29/2013; 20130129-K, Exp 4/29/2013; 20130129-L, Exp 4/29/2013; 20130129-M, Exp 4/29/2013; 20130131-I, Exp 4/30/2013; 20130131-J, Exp 4/30/2013; 20130131-K, Exp 4/30/2013; 20130201-B, Exp 5/1/2013; 20130201-C, Exp 5/1/2013; 20130211-A, Exp 5/11/2013; 20130211-B, Exp 5/11/2013; 20130211-C, Exp 5/11/2013; 20130211-D, Exp 5/11/2013; 20130211-E, Exp 5/11/2013; 20130211-F, Exp 5/11/2013; 2013021

code_info

Lot #: Sodium Bicarb 4.2% 5 mL PF: 130123150AE, Exp 4/23/2013; b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L, Exp 6/15/20…

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, Exp 4/17/2013; 20130117-F, Exp 4/17/2013; 20130121-B, Exp 4/21/2013; 20130121-C, Exp 4/21/2013; 20130121-D, Exp 4/21/2013; 20130121-E, Exp 4/21/2013; 20130121-F, Exp 4/21/2013; 20130121-H, Exp 4/21/2013; 20130121-I, Exp 4/21/2013; 20130121-J, Exp 4/21/2013; 20130121-K, Exp 4/21/2013; 20130124-D, Exp 4/24/2013; 20130124-E, Exp 4/24/2013; 20130129-B, Exp 4/29/2013; 20130129-C, Exp 4/29/2013; 20130129-D, Exp 4/29/2013; 20130129-K, Exp 4/29/2013; 20130129-L, Exp 4/29/2013; 20130129-M, Exp 4/29/2013; 20130131-I, Exp 4/30/2013; 20130131-J, Exp 4/30/2013; 20130131-K, Exp 4/30/2013; 20130201-B, Exp 5/1/2013; 20130201-C, Exp 5/1/2013; 20130211-A, Exp 5/11/2013; 20130211-B, Exp 5/11/2013; 20130211-C, Exp 5/11/2013; 20130211-D, Exp 5/11/2013; 20130211-E, Exp 5/11/2013; 20130211-F, Exp 5/11/2013; 2013021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-407-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.