Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number: D-358-2013

Firm: FVS Holdings, Inc. dba. Green Valley Drugs

Classification: Class II

Status: Terminated

Report Date: 20130522

Initiation Date: 20130410

Termination Date: 20140321

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.

Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.