FDA-Drug2013-05-22Class II

Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, 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
6292 vials
Manufactured in
1850 Whitney Mesa Dr, Suite 180, Henderson, NV, United States
Products
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, 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-355-2013

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