drugs Class II Updated 2013-05-22

FVS Holdings, Inc. dba. Green Valley Drugs recalls Dexamethasone Sodium Phosphate Injection, all strengths and

Recalled Product

Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Lot #: a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F, Exp 7/2/2013; b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H, Exp 6/7/2013; c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B, Exp 4/17/2013; 20130326-C, Exp 6/26/2013; 20130307-E, Exp 6/7/2013; 20130221-D, Exp 5/21/2013; d) Dexamethasone-4mg/5ml P.F.: 20130328-L, Exp 6/28/2013

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