FDAFDA · Food and drugs·Recall number D-346-2013
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, 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) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2, Exp 6/20/2013; 13011650GV7, Exp 4/16/2013; 13012330GV1, Exp 4/23/2013; 13020525Gv1, Exp 5/5/2013; c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2, Exp 5/4/2013; 13031230GV1, Exp 6/12/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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