Reported May 22, 2013 · Terminated
Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate…
FVS Holdings, Inc. dba. Green Valley Drugs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FVS Holdings, Inc. dba. Green Valley Drugs · 1850 Whitney Mesa Dr · Henderson, NV · 89014-2091
Is this the product you have?
- Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Lot codes and dates
- Lot #: a) Edetate Disodium_150/30
- mL
20130201-EExp 5/2/2013b) Edetate Disodium_150/100
- mL
20130124-B4/24/201320130213-BExp 5/13/201320130213-CExp 5/13/201320130401-BExp 7/1/2013
- Amount recalled
- 98 vials
This recall covers 78 products
The agency filed one notice per product. You are reading one of them; the other 77 are below.
65 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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