Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number: D-393-2013

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.

Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.