Product Detail

Product Description ED Mix Injections, all strengths and all presentations including

a) ED mix TM -at 2,
b) ED-Mix BI-Mix 10 30 mL,
c) ED-Mix BI-Mix 9 30 mL;
d) ED-Mix BI-Mix-3-30,
e) ED-Mix PGE 80-30,
f) ED-Mix SB4 30 mL,
g) Ed-Mix ST 9E,
h) ED-Mix ST-1,
i) ED-MIX T106
j) ED-MIX-PGE-150 30 mL,
k) ED-MIX-PGE-40-30,
l) ED-MIX-ST 9A,
m) ED-MIX-ST 9D
n) ED-MIX-ST-9B,
o) ED-MIX-T 101,
p) ED-MIX-T105,
Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number D-363-2013

Classification Class II

Code Info Lot #:
a) ED mix TM -at 2: 20130306-M, Exp 6/6/2013;
b) ED-Mix BI-Mix 10 30 mL: 130207120AE, Exp 5/7/2013;
c) ED-Mix BI-Mix 9 30 mL: 20130121-G, Exp 4/21/2013; 20130301-F, Exp 5/1/2013;
d) ED-Mix BI-Mix-3-30: 20130124-H, Exp 4/24/2013; 20130305-J, Exp 6/5/2013;
e) ED-Mix PGE 80-30: 1302041000AE, Exp 5/4/2013; 20130313-B, Exp 6/13/2013; 20130322-H, Exp 6/22/2013; 20130405-I, Exp 7/5/2013;
f) ED-Mix SB4 30 mL: 130304150AE, Exp 6/4/2013;
g) Ed-Mix ST 9E: 2013220-C, Exp 5/20/2013;
h) ED-Mix ST-1: 20130313-A, Exp 6/13/2013; 20130322-l, Exp 6/22/2013; 20120220-H, Exp 5/20/2013; 20130208-I, Exp 5/8/2013;
i) ED-MIX T106: 20130322-M, Exp 6/22/2013; 20130204-L, Exp 5/4/2013; 20130313-D, Exp 6/13/2013; 20130306-R, Exp 6/6/2013; 20130401-H, Exp 7/1/2013;
j) ED-MIX-PGE-150 30 mL: 20130401-J, Exp 7/1/2013;
k) ED-MIX-PGE-40-30: 20130307-B, Exp 6/7/2013; 20130322-I, Exp 6/22/2013;
l) ED-MIX-ST 9A: 20130401-K, Exp 7/1/2013;
m) ED-MIX-ST 9D: 20130401-L, Exp 7/1/2013;
n) ED-MIX-ST-9B: 20130327-A, Exp 6/27/2013;
o) ED-MIX-T 101: 20130322-J, Exp 6/22/2013; 20130220-D, Exp 5/20/2013
p) ED-MIX-T105: 20130322-K, Exp 6/22/2013; 20130204-K, Exp 5/4/2013; 20130220-F, Exp 5/20/2013; 20130401-I, Exp 7/1/2013

Product Distributed Qty 10684 vials

Reason For Recall 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.

Event Detail

Event Id 64879

Product Type Drugs

Status Ongoing

Recalling Firm FVS Holdings, Inc. dba. Green Valley Drugs, Henderson, NV, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-10

Initial Firm Notification of Consignee or Public Press Release

Distribution Pattern Nationwide