drugs Class II Updated 2013-05-22

FVS Holdings, Inc. dba. Green Valley Drugs recalls Betamethasone Combination with Lidocaine 1% and Bupivacaine

Recalled Product

Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, 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) Betameth combo 6mg/ml lido1% bup 0.5% syr: 13021975, Exp 5/19/2013; b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr: 13012550, Exp 4/25/2013; 130215100, Exp 5/15/2013

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