FDAFDA · Food and drugs·Recall number D-385-2013
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, 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) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G, Exp 7/5/2013; c) Manganese Sulfate 5 mg/5 mL: 20130122-4, Exp 4/22/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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