FDAFDA · Food and drugs·Recall number D-408-2013
Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Published May 22, 2013 · Recall initiated: April 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Distributor
- Nationwide
- Lot
- Lot #: a) Bacteriostatic Sodium Chloride 0.9% 30 mL, 20121205, Exp 6/11/2013; b) Sodium Chloride 23.4% 30 mL PF: 20130115-G, Exp 4/15/2013; c) Sodium Chloride 23.4% 50 mL: 20130114-E, Exp 4/14/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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