ED Mix Injections recall: Sterility Concern
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…
Why was ED Mix Injections 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Quantity
- 10684 vials
- Distribution
- Nationwide
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)