Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number: D-359-2013

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.

Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.