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Recall Observatory FDA recall evidence

Drug product

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.

D-363-2013

April 10, 2013

Class II

Product summary

Firm
FVS Holdings, Inc. dba. Green Valley Drugs
Event
Event 64879
Status
Terminated
Classification
Class II
Quantity
10684 vials
Official record key
drug-enforcement:D-363-2013

Official wording

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.

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility