FDA-Drug2013-05-22Class II

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.

FVS Holdings, Inc. dba. Green Valley Drugs
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.

Sold states
Nationwide
Affected count
756 vials
Manufactured in
1850 Whitney Mesa Dr, Suite 180, Henderson, NV, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-352-2013

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