drugs Class II Updated 2013-05-22

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

Recalled Product

Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, 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) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C, Exp 6/18/2013; 20130319-F, Exp 6/19/2013; b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E, Exp 5/12/2013; 20130124-F, Exp 4/24/2013; 20130214-G, Exp 5/14/2013; 20130320-E, Exp 6/20/2013
View official government recall

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