Recalls / Class II
Class IID-363-2013
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.
- Affected lot / 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
Why it was recalled
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.
Recalling firm
- Firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1850 Whitney Mesa Dr, Suite 180, Henderson, Nevada 89014-2091
Distribution
- Quantity
- 10684 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-10
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2014-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-363-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.