FDAFDA · Food and drugs·Recall number D-366-2013
Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 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) Folic Acid 10 mg/30 mL: 20130204-D, Exp 5/4/2013; b) Folic Acid PF 10mg/mL 2 mL: 20130219-E, Exp 5/15/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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