drugs Class II Updated 2013-05-22

FVS Holdings, Inc. dba. Green Valley Drugs recalls Polidocanol Injection, all strengths and all presentations i

Recalled Product

Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, 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 #: Polidocanol 5% 30 mL: 20130319-I, Exp 6/19/2013; 20130326-H, Exp 6/26/2013; b) Polidocanol 1% 30 mL: 20130118-B, Exp 4/18/2013

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